Lead Test and Inspection Method Validation activities (TMV/IMV) Support risk management activities such as process Failure Mode and Effects Analysis updates (pFMEA’s)
Support CAPA or nonconforming material (NCMR) related investigation or validation activities
Work closely with suppliers of electronic and mechanical parts on manufacturing and quality topics such as Supplier Corrective and Preventive Actions (SCAR’s) and Supplier Change Requests (SCR’s)
Propose new or improved technologies and processes to enhance product quality, manufacturing efficiencies, cost, and regulatory compliance
Drive continuous and measurable improvements OPEX (Operational Excellence)
Participate in internal and external audits as SME for process validation
THE PROFILE
Master’s degree/bachelor’s in electrical engineering, Mechanical Engineering, Industrial Engineering or similar (ETH/FH or comparable education)
5 years or more of experience in a similar position in Med-Tech industry Detailed knowledge of medical standards like ISO 13485, FDA 21CFR820, ISO 14971, IEC 60601-1, MDSAP, GMP, GDP, IMRDF (GHTF)
Proven expertise in EU MDR regulations and cross-functional department coordination. Leading MDR-related projects will be considered a plus.
Proven expertise in risk analysis (FMEA), process and test method validation (TMV/IMV, IQ/OQ/PQ)
Detailed knowledge of statistical methods, techniques, and software tools to analyze data such as Minitab
Experience in manufacturing of electronic or Electromechanical products is a plus, Knowledge of SAP (ERP system), Windchill (PLM and Change Order system), Solid Works (CAD), Power BI is a plus
Experience in EUMDR Class III and Class II Medical devices submissions, Obsolescence Management and Various Manufacturing Process (Injection molding) considered a plus
Technical Project Management: Ability to lead smaller Project independently
English Level C2 is required, German language skills are considered a plus
Flexible team player with accurate working and documentation style
Excellent analytical and creative problem-solving skills and process thinking
Proficient in Microsoft applications (PowerPoint, Word, Excel, Visio)
Risk management activities according to ISO 14971:2019, certification is a plus
Black belt six sigma certification is required
Why Join Abbott?
Make a direct impact on technologies that help save and improve patients' lives.
Lead critical industrialization activities for a next-generation circulatory support platform.
Collaborate within a truly global team spanning Zurich, Switzerland and Pleasanton, California.
Influence both product design and manufacturing strategy early in the development process.
Work with advanced electromechanical medical technology in a highly innovative environment.
Grow your career within one of the world's leading healthcare companies.
The Best of Both Worlds
Our Zurich Heart Failure site is home to approximately 160 employees, offering the visibility, ownership, agility, and family-like culture often associated with a smaller organization. Here, you can see the direct impact of your work, build strong cross-functional relationships, and influence key decisions.
At the same time, you will be part of Abbott's global organization, collaborating closely with teams in Pleasanton, California and around the world while benefiting from the resources, stability, technology leadership, and career opportunities of one of the world's leading healthcare companies.
Ready to Apply?
We're looking for curious, driven engineers who thrive in dynamic environments and enjoy transforming innovative ideas into robust manufacturing solutions. Even if your experience does not align perfectly with every qualification, we encourage you to apply.
Join Abbott and help bring life-saving technologies to patients around the world.
