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 LifeAs a Quality Engineering Manager at Medtronic, you will lead and manage teams responsible for maintaining the highest standards of product reliability and patient well-being through comprehensive risk management and post-market quality activities. You will play a pivotal role in ensuring product safety, compliance, and continuous improvement.
Responsibilities may include the following and other duties may be assigned
- Lead and mentor cross-functional teams to develop comprehensive product risk management files, including risk management plans, Hazard Analysis, DFMEA, and risk management reports, adhering to ISO 14971 standards.
- Oversee the preparation and compilation of product post-market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements.
- Collaborate with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
- Conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements.
- Ensure compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
- Review Design History Files and Technical Files to ensure alignment with applicable requirements.
- Deliver presentations on project status and issues to the QA organization and provide training to other departments on relevant procedures and policies.
- Participate in audits and demonstrate the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator.
- Provide quality support to facilitate the resolution of product complaints and/or safety issues.
- Develop templates and training based on quality system regulations, applicable standards, and guidance.
- Independently review all deliverables to ensure compliance with development processes and standards.
- Stay updated with evolving safety regulations and guidelines to ensure compliance.
Required Knowledge and Experience
- B.E. or B.Tech in Mechanical/Biomedical Engineering.
- Minimum 16+ years of quality engineering experience, with at least 5+ years in a managerial role in medical device domain
- Capability to conduct thorough reviews of product design documentation and assess quality characteristics.
- Subject matter expert in risk management and post-market quality for medical devices.
- Hands-on experience with complaints analysis, post-market surveillance, and design controls for medical devices.
- Experience in collaborating with regulatory affairs teams for the submission of safety reports.
- Strong verbal and written communication skills.
- Familiarity with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EU MDR, and product-specific industry standards.
- Working knowledge of and auditing experience with FDA Quality System Regulations, ISO 13485, and the Medical Device Regulation.
- Understanding of post-market surveillance processes and adverse event reporting.
- Knowledge of risk management principles and hazard analysis in the context of medical devices.
- Familiarity with DMAIC or DMADV (DFSS) methodologies.
- Leadership: Proven ability to lead, mentor, and develop high-performing teams, fostering a collaborative and inclusive work environment.
- Communication: Excellent verbal and written communication skills, with the ability to convey complex information clearly and effectively to diverse audiences.
- Problem-Solving: Strong analytical and problem-solving skills, with a proactive approach to identifying and addressing issues.
- Interpersonal Skills: Ability to build and maintain strong relationships with cross-functional teams, stakeholders, and regulatory authorities.
- Adaptability: Demonstrated ability to adapt to changing priorities and manage multiple projects simultaneously in a fast-paced environment.
- Conflict Resolution: Skilled in conflict resolution and negotiation, with the ability to handle challenging situations with professionalism and tact.
- Decision-Making: Strong decision-making skills, with the ability to make informed and timely decisions that align with organizational goals.
- Medical Device domain: Ability to understand the functionality / intended use of complex medical devices.
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 & CompensationMedtronic 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 MedtronicWe 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 90,000+ 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
