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 Quality Engineer position offers a unique opportunity to contribute to the development and industrialization of innovative medical devices in a highly regulated environment. As a key member of cross functional project teams, you will play a critical role in ensuring quality and regulatory readiness throughout product and process development, from early design phases through design transfer and manufacturing scale up. This role is ideal for a Quality Engineer who is motivated by pre market activities, enjoys working in a project driven environment, and wants to have a direct impact on bringing safe and effective medical technologies to patients.
This position is based at the SMO Tolochenaz site and requires regular on site presence to effectively support product development, industrialization, and design transfer activities. The role operates in a highly collaborative, cross functional environment, working closely with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality teams. Occasional travel may be required to support manufacturing partners, suppliers, or project meetings, depending on project needs. This is a 24 month fixed term contract designed to support key pre market initiatives and business priorities.
Responsibilities may include the following and other duties may be assigned:
1. Supports design transfer from R&D to Manufacturing, including risk management activities, process validation, and manufacturing readiness.
2. Acts as a quality partner within cross functional project teams to ensure quality and regulatory readiness prior to product launch or product transfer.
3. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
4. Collaborate with development team on NPI, definition of strategies for validation and qualification of processes and equipment, support characterization of processes through structural approach and usage of Design for Reliability and Manufacturability.
5. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
6. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
7. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
8. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
9. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
10. Provides quality support to pre market projects, including product development, process development, industrialization, and product transfer activities.
11. Ensure quality deliverables are defined and executed throughout design and process development phases in compliance with Design Control requirements.
Required Knowledge and Experience:
12. Master’s degree or equivalent, with at least 2 years of experience.
13. English min B2.
14. Strong working knowledge of Quality Management Systems (QMS) compliant with:
- ISO 13485 and MDSAP and applicable global regulations
15. Hands-on experience with:
- Design Controls
- Risk Management
- CAPA, NCR, Deviation management
- Change Control
16. Experience supporting regulatory inspections and audits (FDA, Notified Bodies).
17. Solid understanding of software and/or hardware validation (as applicable).
18. Ability to work cross-functionally with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality.
19. Strong documentation, analytical, and problem-solving skills.
20. Experience supporting pre market quality activities within product and/or process development projects.
21. Working knowledge of design transfer and industrialization activities in a regulated medical device environment.
22. Experience contributing to pre market documentation such as Design History File (DHF), risk management files, and validation documentation.
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.
Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Switzerland: 92,000.00 CHF - 138,000.00 CHF |
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