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
This position is for quality engineering support with Medical device industry experience of strong expertise in Design History File (DHF) remediation and Risk Management activities to support compliance, audit readiness and product quality improvements. The role involves reviewing legacy design documentation, ensuring alignment with regulatory standards (ISO 13485, 21 CFR part 820, EU MDR 2017/745), process & procedures and strengthening risk management practices (ISO 14971) across product lifecycles.
Responsibilities may include the following and other duties may be assigned:
Must have:
- Ensure legacy design documentation is accurately migrated and aligned with current Medtronic templates and standards
- Ensure DHF & risk management files alignment with design control requirements and internal quality procedures.
- Review, assess, and remediate legacy DHFs (including risk management files) to ensure completeness and compliance with regulatory requirements (e.g. FDA, EU MDR).
- Participate with cross-functional teams to review DHF files & technical files, identify gaps & drive remediation with respect to standards such as FDA 21 CFR 820, ISO 13485, ISO 14971 and EU MDR.
- Revise or create documentation related to design controls, risk management, verification and validation, design reviews and change management.
- Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
- Identify gaps in design documentation including requirements, verification/validation, traceability and design reviews.
- Develop product risk management file (risk management plan, risk assessments, DFMEA and risk management report) as per ISO 14971 standard and internal procedures.
- Ensure complete bidirectional traceability from user needs through design inputs, outputs, V&V, and risk controls.
- Establish clear traceability between hazards, harms, hazardous situations, and mitigations in risk management files.
- Deep understanding of Change Development Process and structured change management systems.
- Comfortable working with international cross functional teams in different time zones.
- Previous experience working in a cross-functional team environment and remediation activities.
- Good verbal and written communication skills including protocol / report development and technical presentations.
- Strong in design and development, verification and validation and risk management.
- Good interpersonal skills and ability to work in a fast-paced environment.
Required Knowledge and Experience:
- B E or B. Tech in Mechanical/Biomedical engineering
- Minimum 3-5 years of quality engineering experience or equivalence and overall 5-8 years of experience.
Nice to have: - ISO 13485 Internal Auditor / Lead Auditor Certification
- Experience in Test Method Validation (TMV) including statistical justification and GR&R
- Strong understanding of statistical tools for validation and sampling rationale.
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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
