87 Manufacturing Engineer jobs in Hyderabad
Manufacturing Engineer II
Posted 8 days ago
Job Viewed
Job Description
**A Day in the Life**
Careers That Change Lives
At Medtronic, you can begin a lifelong career of exploration and innovation while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Be a part of the Medtronic Engineering and Innovation Center (MEIC) by applying your skills to the growth and development of the Global Manufacturing Group team. Collaborate closely with stakeholders on tasks and projects to ensure the timely and successful completion of assignments.
**A Day in the Life**
**Responsibilities may include the following and other duties may be assigned:**
+ Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, material handling, and processing.
+ Create efficient and productive layouts by designing machine arrangements within plant facilities.
+ Specify procedures and sequence of operations for fabrication tools, equipment, and production processes, ensuring optimal product performance.
+ Collaborate with internal manufacturing sites and suppliers to design, characterize, and qualify high-capability processes for consistent product output, including process flows and control plans.
+ Develop and maintain manufacturing processes aligned with statistical process control, risk mitigation (pFMEA), and regulatory requirements like ISO 13485 and FDA 21 CFR Part 820.
+ Prepare and review validation plans, protocols, and procedures (IQ, OQ, PQ, MVR) for successful transfer activities.
+ Inspect and troubleshoot machinery and equipment to maintain product quality, initiating corrective actions as necessary.
+ Provide engineering support regarding design concepts, specification requirements, and best practices for manufacturing techniques.
+ Present technical findings and project statuses to cross-functional teams and management.
+ Adapt machine or equipment designs to factory and production conditions.
+ Ensure that all processes and procedures comply with relevant regulations.
**TECHNICAL SPECIALIST CAREER STREAM**
An individual contributor responsible for advancing existing technology or introducing new technologies and therapies. You will formulate, deliver, and manage assigned projects, working with stakeholders to achieve desired results. You may also act as a mentor to colleagues or lead lower-level professionals. Most of your time will be spent on R&D and implementation of new technologies, from design to production, while adhering to Medtronic's policies and utilizing your specialized knowledge and skills.
**DIFFERENTIATING FACTORS**
**Autonomy:**
You are an established, productive individual contributor who works independently with general supervision on larger, moderately complex projects or assignments.
**Organizational Impact:**
Your contributions will help achieve project milestones and may involve cross-functional collaboration.
**Innovation and Complexity:**
Problems and issues you face may require understanding broader sets of issues. You will make recommendations and improvements to systems and processes to enhance efficiency.
**Communication and Influence:**
You will primarily communicate with internal contacts and share information to inform decision-making. External communication is less frequent and usually related to problem-solving.
**Leadership and Talent Management:**
You may provide guidance and assistance to entry-level professionals or employees in the support career stream.
**Must Have: Minimum Requirements**
+ **Education:** Bachelor's degree in mechanical engineering or a related field with 5-8 years of relevant experience, or an advanced degree with 2+ years of experience in mechanical design, product development, or design verification/validation.
+ **Experience:** Strong understanding of manufacturing process validation (Master Validation Planning, IQ, OQ, PQ) and Lean Manufacturing/Six Sigma methodologies.
+ **Skills:** Proficiency in GD&T, interpreting mechanical drawings, and statistical analysis tools such as Design of Experiments (DOE). Experience with machining, molding, assembly processes, and risk management tools (pFMEA, dFMEA).
**Nice to Have**
+ Medical device product development or manufacturing experience, with a solid understanding of FDA and ISO standards.
+ Proficiency in CAD software like SolidWorks or similar for mechanical design and analysis.
+ Experience across the entire product lifecycle, from design to manufacturing.
+ Project engineering or program management experience.
+ Strong problem-solving skills, with a focus on structured methodologies like Design for Six Sigma, DFMA, DRM, and Lean Manufacturing.
**Physical Job Requirements**
The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.
**Benefits & Compensation**
Medtronic offers a competitive salary and flexible benefits package. We are committed to our employees' well-being and success and recognize their contributions. We offer a wide range of benefits, resources, and compensation plans designed to support you at every stage of your career.
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. Join us and be part of a team that accelerates healthcare innovation.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
Senior Manufacturing Engineer

Posted 16 days ago
Job Viewed
Job Description
**A Day in the Life**
Careers that Change Lives
Be a part of the Medtronic Engineering and Innovation Center (MEIC) in Hyderabad by applying your skills to the growth, development, on Medical Devices products for the Global.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations
**A Day in the Life**
Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development of Supplier Optimization team under Global supply mangement group team within MEIC.
As a member of GO & SC group you will collaborate closely with all the necessary stakeholders on the assigned tasks and projects including your counterparts in the US to ensure timely and successful completion of the same
The Prin. Manufacturing Engineer will closely collaborate with cross-functional project teams within MEIC and GOUs. This role involves leading medium to high complexity supplier transfers and optimization projects, focusing on vertical integrations, cost optimizations and supply chain management. The incumbent will be instrumental in fostering business engagements, enhancing value through process improvements, and adopting best practices.
**Validation Processes:**
+ Conduct Operational Qualification (OQ) and Performance Qualification (PQ) processes.
+ Assist in developing Master Validation Plans, including process flow, OQ, and PQ.
**Statistical Analysis:**
+ Perform CPK (Process Capability Index) and ANOVA (Analysis of Variance) studies.
+ Conduct criticality analysis to ensure process reliability and quality.
**Measurement System Analysis (MSA):**
+ Perform GR&R (Gage Repeatability and Reproducibility) studies.
+ Identify and implement appropriate types of MSA.
**Risk Management:**
+ Conduct PFMEA (Process Failure Mode and Effects Analysis) and calculate Risk Priority Numbers (RPN).
**Documentation:**
+ Develop and maintain work instructions, ensuring they are clear and comprehensive
**Must-Have:**
+ Minimum of 8-12 years of relevant experience.
+ Minitab software
+ Hands-on experience in manufacturing Engineering projects
+ Familiarity with Regulated manufacturing environment
+ Excellent interpersonal, influence management, and conflict resolution skills.
+ Strong written, verbal, and presentation skills.
+ Effective planning and organization skills, including the ability to work against multiple objectives simultaneously.
+ Bachelor of Engineering in Mechanical or related (Electircal, electronics) Engineering field.
**Nice to Have:**
+ Project management skills with a track record of managing projects to schedule, budget, and scope.
+ Master's degree
+ Manufacturing process knowledge
+ GD&T Certification
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
Advanced Manufacturing Engineer
Posted 1 day ago
Job Viewed
Job Description
Responsibilities:
- Design, develop, and implement advanced manufacturing processes and systems.
- Optimize existing production lines for efficiency, quality, and cost-effectiveness.
- Lead projects related to automation, robotics, and Industry 4.0 initiatives.
- Evaluate and select new manufacturing technologies and equipment.
- Develop and implement lean manufacturing and Six Sigma methodologies.
- Collaborate with product design teams to ensure manufacturability of new products.
- Develop and maintain process documentation, work instructions, and standard operating procedures.
- Troubleshoot manufacturing issues and implement corrective actions.
- Analyze production data to identify areas for improvement.
- Train production staff on new processes and technologies.
Qualifications:
- Bachelor's or Master's degree in Mechanical Engineering, Industrial Engineering, or a related field.
- Minimum of 7 years of experience in manufacturing engineering, with a focus on advanced manufacturing technologies.
- Proven experience with automation, robotics, and PLC programming.
- Hands-on experience with technologies such as additive manufacturing (3D printing), CNC machining, or advanced materials.
- Strong understanding of lean manufacturing principles, Six Sigma, and quality control systems.
- Proficiency in CAD/CAM software and process simulation tools.
- Excellent problem-solving, analytical, and project management skills.
- Strong communication and interpersonal skills, with the ability to lead cross-functional teams.
- Experience working in a fast-paced production environment.
- Knowledge of Industry 4.0 concepts and implementation.
Senior Manufacturing Engineer
Posted 6 days ago
Job Viewed
Job Description
Manufacturing Engineer II
Posted today
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Careers That Change LivesAt Medtronic, you can begin a lifelong career of exploration and innovation while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Be a part of the Medtronic Engineering and Innovation Center (MEIC) by applying your skills to the growth and development of the Global Manufacturing Group team. Collaborate closely with stakeholders on tasks and projects to ensure the timely and successful completion of assignments.
A Day in the Life
Responsibilities may include the following and other duties may be assigned:
TECHNICAL SPECIALIST CAREER STREAM
An individual contributor responsible for advancing existing technology or introducing new technologies and therapies. You will formulate, deliver, and manage assigned projects, working with stakeholders to achieve desired results. You may also act as a mentor to colleagues or lead lower-level professionals. Most of your time will be spent on R&D and implementation of new technologies, from design to production, while adhering to Medtronic’s policies and utilizing your specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy:
You are an established, productive individual contributor who works independently with general supervision on larger, moderately complex projects or assignments.
Organizational Impact:
Your contributions will help achieve project milestones and may involve cross-functional collaboration.
Innovation and Complexity:
Problems and issues you face may require understanding broader sets of issues. You will make recommendations and improvements to systems and processes to enhance efficiency.
Communication and Influence:
You will primarily communicate with internal contacts and share information to inform decision-making. External communication is less frequent and usually related to problem-solving.
Leadership and Talent Management:
You may provide guidance and assistance to entry-level professionals or employees in the support career stream.
Must Have: Minimum Requirements
Nice to Have
Physical Job Requirements
The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. We are committed to our employees' well-being and success and recognize their contributions. We offer a wide range of benefits, resources, and compensation plans designed to support you at every stage of your career.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. Join us and be part of a team that accelerates healthcare innovation.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity
Senior Manufacturing Engineer
Posted today
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
As a Sr Manufacturing Engineer in the ENT Operations Team, you will play a key role in managing projects that are strategic to the business and work cross functionally with various functional managers while driving program execution. Also, this role will engage with the OU leaders through steering meetings, monthly leadership meetings and daily project execution.Responsibilities may include the following and other duties may be assigned
Required Knowledge and Experience
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity
Remote Senior Manufacturing Engineer
Posted today
Job Viewed
Job Description
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Remote Advanced Manufacturing Engineer
Posted 6 days ago
Job Viewed
Job Description
In this critical role, you will leverage your expertise to design, optimize, and implement advanced manufacturing techniques and technologies. You will be responsible for improving production efficiency, enhancing product quality, and reducing costs through the application of cutting-edge methodologies. This position requires a strong understanding of automation, robotics, lean manufacturing, and quality control principles. You will collaborate with engineering and production teams globally to identify areas for process improvement and implement scalable solutions. The ideal candidate possesses a keen eye for detail, exceptional problem-solving skills, and a passion for manufacturing excellence. Your contributions will directly impact the efficiency and competitiveness of our client's production operations.
Key responsibilities include:
- Developing and implementing advanced manufacturing processes, including automation and robotics.
- Analyzing existing manufacturing workflows to identify bottlenecks and areas for improvement.
- Designing and implementing lean manufacturing principles to optimize efficiency and reduce waste.
- Creating and maintaining detailed process documentation and standard operating procedures.
- Collaborating with R&D teams to integrate new product designs into manufacturing processes.
- Developing and executing validation plans for new manufacturing equipment and processes.
- Troubleshooting production issues and implementing corrective actions.
- Utilizing statistical process control (SPC) and other quality tools to ensure product consistency.
- Providing technical support and training to manufacturing personnel.
- Researching and recommending new manufacturing technologies and equipment.
A Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related discipline is required. A Master's degree is a plus. A minimum of 7 years of experience in advanced manufacturing environments, with a focus on process improvement and automation, is essential. Proficiency in CAD/CAM software, PLC programming, and statistical analysis tools is highly desirable. Strong knowledge of lean manufacturing, Six Sigma methodologies, and quality management systems (e.g., ISO 9001) is expected. Excellent communication and interpersonal skills, coupled with the ability to work effectively in a remote, collaborative environment, are critical for success in this role. This position offers a competitive compensation package and the chance to shape the future of manufacturing.
Remote Senior Manufacturing Engineer
Posted 6 days ago
Job Viewed
Job Description
Key Responsibilities:
- Optimize manufacturing processes for efficiency, quality, and cost-effectiveness.
- Implement lean manufacturing principles and continuous improvement initiatives.
- Analyze production data to identify areas for improvement and implement solutions.
- Design, develop, and validate manufacturing processes and equipment.
- Lead root cause analysis for production issues and implement corrective actions.
- Collaborate with cross-functional teams on new product introduction (NPI).
- Develop and maintain manufacturing documentation, including SOPs and work instructions.
- Evaluate and implement new manufacturing technologies and automation.
- Ensure compliance with safety regulations and quality standards.
- Mentor junior manufacturing engineers.
Qualifications:
- Bachelor's degree in Mechanical, Industrial, or Manufacturing Engineering.
- Minimum 5 years of experience in manufacturing engineering.
- Proficiency in lean manufacturing, Six Sigma, and process improvement methodologies.
- Experience with automation and manufacturing technologies.
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration skills for remote teamwork.
- Experience with CAD/CAM software and statistical analysis tools.
- Master's degree or relevant certifications (e.g., Black Belt) is a plus.
Senior Manufacturing Engineer - Medical Devices
Posted today
Job Viewed
Job Description
Job Title: Manufacturing Engineer – Medical Devices (Senior/Principal Level)(Remote)
Location: Hyderabad, IND
Employment Type: Part-time
Position Summary:
We are seeking an experienced Manufacturing Engineer Trainer with 10+ years of hands-on expertise in the medical device industry to support and enhance our manufacturing operations. The ideal candidate will have a proven track record in process development, validation, scale-up, and continuous improvement while ensuring compliance with FDA, ISO 13485, and GMP regulations .
Key Responsibilities:
- Lead the design, development, and optimization of manufacturing processes for Class II/III medical devices.
- Drive process validation activities, including IQ, OQ, PQ, and Test Method Validation in compliance with regulatory requirements.
- Collaborate with R&D, Quality, and Regulatory teams to ensure smooth transfer of products from design to full-scale manufacturing.
- Identify, analyze, and resolve complex manufacturing challenges to improve efficiency, cost-effectiveness, and product quality.
- Oversee equipment selection, installation, and qualification (IQ/OQ/PQ), ensuring robust process capability.
- Lead continuous improvement initiatives using Lean, Six Sigma, and other structured problem-solving methodologies.
- Provide technical leadership and mentorship to junior engineers and technicians.
- Support audits (internal, supplier, and regulatory) by preparing technical documentation and ensuring compliance with ISO 13485, FDA 21 CFR Part 11/820, and EU MDR .
- Manage nonconformance investigations, root cause analysis, and corrective/preventive actions (CAPA) .
- Collaborate with suppliers to ensure incoming materials meet specifications and quality standards.
Qualifications:
- Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related Engineering field (Master’s preferred).
- 10+ years of progressive experience in manufacturing engineering within the medical device industry.
- Strong background in process validation, design transfer, and GMP manufacturing operations .
- Proficiency in Lean Manufacturing, Six Sigma (Green/Black Belt preferred).
- Experience with CAD software, statistical analysis tools, and ERP/MES systems.
- In-depth knowledge of FDA, ISO 13485, ISO 14971, and EU MDR regulations .
- Demonstrated leadership in cross-functional teams and mentoring junior staff.
- Excellent communication, documentation, and project management skills.