Senior Technical Specialist - Process Validation
Shape the Future of Mechanical Circulatory Support
Join Abbott's Heart Failure business and play a key role in bringing the next generation of Circulatory Support Systems from development into global manufacturing.
Become part of a great team which is responsible for establishing and maintaining processes along the entire supply chain and manufacturing of life-supporting medical devices which are based on the fascinating technology of magnetic levitation. With your work you’ll ensure our products and processes meet the high standards of our industry and are inline with our policy “built as intended for your family”. In your role you will be interfacing and collaborating with cross-functional teams in Switzerland and the USA.
MAIN RESPONSIBILITIES
- Accountable for process validation planning and execution including supplier process validations, e.g. Master Validation Planning (MVP/MVR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ) and Supplier Process Validation (SPV)
- Creation and maintenance of validation documentation, e.g. validation protocols, validation reports and supporting documentation such as change orders, risk analysis, deviation reports, etc.
- Maintain a strong presence on the manufacturing floor, working directly with processes, equipment, and operators to execute validations, investigate issues, verify process performance, and drive practical, data-driven improvements
- 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.