Join Thoratec Switzerland GmbH
Thoratec Switzerland GmbH is part of the medical device division of Abbott Laboratories, a Fortune 500 company with over 115,000 employees worldwide. We are the global market leader in implantable and extracorporeal blood pumps based on magnetic levitation technology. Our life-saving systems, developed and manufactured in Zurich, cater to advanced heart failure patients requiring short- or long-term circulatory support.
Located in the heart of Zurich, our team of around 130 employees focuses on the development, quality, and production of the CentriMag system and HeartMate 3. We are currently seeking a motivated and talented Senior Technical Specialist (Temporary, start date: 1st July 2025 - until Dec 2026) to join our dynamic team.
Main Responsibilities
- Accountable for 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).
- Creation and maintenance of validation documentation, including validation protocols, validation reports, and supporting documentation like change orders, risk analysis, and deviation reports.
- Lead Test and Inspection Method Validation activities (TMV/IMV).
- Support risk management activities, including process Failure Mode and Effects Analysis updates (pFMEA).
- Assist with CAPA or nonconforming material (NCMR) related investigation or validation activities.
- Collaborate closely with suppliers of electronic and mechanical parts on manufacturing and quality topics, such as Supplier Corrective and Preventive Actions (SCAR) and Supplier Change Requests (SCR).
- Propose new or improved technologies and processes to enhance product quality, manufacturing efficiencies, cost, and regulatory compliance.
- Drive continuous and measurable improvements in Operational Excellence (OPEX).
- Participate in internal and external audits as a Subject Matter Expert 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 education).
- 10-12 years of relevant experience in a similar position within the Med-Tech industry.
- In-depth knowledge of medical standards such as ISO 13485, FDA 21CFR820, ISO 14971, IEC 60601-1, MDSAP, GMP, GDP, and IMRDF (GHTF).
- Proven expertise in EU MDR regulations and cross-functional department coordination; experience leading MDR-related projects is a plus.
- Solid understanding of risk analysis (FMEA), process and test method validation (TMV/IMV, IQ/OQ/PQ).
- Proficient in statistical methods and tools for data analysis, such as Minitab.
- Experience in manufacturing electronic or electromechanical products is an advantage; knowledge of ERP systems like SAP, PLM and Change Order systems like Windchill, CAD software like SolidWorks, and data visualization tools like Power BI is desirable.
- Experience with EUMDR Class III and Class II Medical devices submissions, obsolescence management, and various manufacturing processes (e.g., injection molding) is a plus.
- Technical project management skills with the ability to lead smaller projects independently.
- Fluent in English (Level C2).
- A flexible team player with a meticulous working and documentation style.
- Excellent analytical, creative problem-solving skills, and process-oriented thinking.
- Proficient in Microsoft applications (PowerPoint, Word, Excel, Visio).
- Knowledge of risk management practices according to ISO 14971:2019; certification is a plus.
- Minimum Green Belt Six Sigma certification; Black Belt is a plus.
- Previous experience in other Abbott plants is beneficial.
Working at Abbott
At Abbott, you have the opportunity to do work that matters and help people live healthier, fuller lives. You will have access to:
- Career development within an international company that values growth.
- A position in a Fortune 500 company and a leader in the medical device industry.
- A challenging role in a crisis-independent sector.
- A chance to join a dynamic, highly educated, skilled, and motivated team.
- A multi-national environment that fosters talent development within the enterprise.
- Competitive compensation and benefits.
- A workplace situated in the heart of Zurich.
We are seeking a highly motivated individual who is eager to be part of our passionate team with broad responsibilities. Do you have what it takes? Then apply online using the form below. Only applications matching the job profile will be considered.
Get Started
We look forward to welcoming you to our team in Zurich!