Senior Technical Specialist (Temporary)
Join Thoratec Switzerland GmbH, a leading company in the field of medical devices, which is a proud member of Abbott Laboratories— a Fortune 500 company employing over 115,000 individuals globally. As the global market leader in implantable and extracorporeal blood pumps utilizing innovative magnetic levitation technology, we develop and manufacture life-saving systems in Zurich for patients suffering from advanced heart failure.
Our Zurich location, nestled in the heart of the city, is home to around 130 passionate employees engaged in the development, quality assurance, and production of the CentriMag system and the HeartMate 3. We are currently seeking a motivated and talented Senior Technical Specialist for a temporary position scheduled to commence on July 1, 2025, until December 2026.
Main Responsibilities
- Oversee process validation planning and execution, including supplier process validations such as Master Validation Planning (MVP/MVR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ), and Supplier Process Validation (SPV).
- Create and maintain comprehensive validation documentation, including validation protocols, validation reports, and supporting documents such as change orders, risk analysis, and deviation reports.
- Lead Test and Inspection Method Validation activities (TMV/IMV) and support risk management activities, including process Failure Mode and Effects Analysis updates (pFMEA’s).
- Assist in CAPA or nonconforming material (NCMR) related investigations and validation activities.
- Collaborate closely with suppliers of electronic and mechanical components on manufacturing and quality issues, including Supplier Corrective and Preventive Actions (SCAR’s) and Supplier Change Requests (SCR’s).
- Propose innovative technologies and processes to improve product quality, enhance manufacturing efficiencies, reduce costs, and ensure regulatory compliance.
- Drive ongoing and measurable improvements through Operational Excellence (OPEX).
- Participate in internal and external audits as a Subject Matter Expert (SME) for process validation.
The Profile
- Master’s degree or Bachelor’s in Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a related field (ETH/FH or comparable).
- 10-12 years of experience in a similar role within the Med-Tech industry.
- In-depth knowledge of medical standards, including ISO 13485, FDA 21CFR820, ISO 14971, IEC 60601-1, MDSAP, GMP, GDP, and IMRDF (GHTF).
- Demonstrated expertise in EU MDR regulations and coordination across cross-functional departments; leading MDR-related projects is a plus.
- Proficient in risk analysis (FMEA), process, and test method validation (TMV/IMV, IQ/OQ/PQ).
- Extensive knowledge of statistical methods, techniques, and software tools for data analysis, such as Minitab.
- Experience in manufacturing electronic or electromechanical products is a plus; familiarity with SAP (ERP), Windchill (PLM), SolidWorks (CAD), and Power BI is advantageous.
- Experience with EUMDR Class III and Class II medical device submissions, obsolescence management, and various manufacturing processes such as injection molding is considered a plus.
- Technical project management skills with the ability to lead smaller projects independently.
- Fluent in English (C2 level required).
- Flexible team player with a meticulous working and documentation style.
- Exceptional analytical and creative problem-solving abilities with a strong process-oriented mindset.
- Proficiency in Microsoft Office applications (PowerPoint, Word, Excel, Visio).
- Familiarity with risk management activities in accordance with ISO 14971:2019; certification is a plus.
- Minimum green belt Six Sigma certification; black belt is preferred.
- Previous experience at other Abbott facilities will be regarded as a plus.
Working at Abbott
At Abbott, you’ll engage in projects that make a significant impact on people's health and well-being. You'll have the opportunity to:
- Advance your career with an international company committed to your professional development.
- Work in a Fortune 500 company, recognized as a leading manufacturer of medical devices.
- Take on a challenging role in a crisis-resistant industry.
- Participate in a dynamic and highly skilled team environment.
- Thrive in a multinational setting that supports talent development.
- Enjoy competitive compensation and benefits.
- Work in a prime location in the heart of Zurich.
If you are a highly motivated individual eager to become part of our passionate team with broad responsibilities, we encourage you to apply online using the form below. Only applications matching the job profile will be considered. We look forward to welcoming you to our team in Zurich!