Senior Technical Specialist / Senior Technical Specialistess

Join Our Team at Thoratec Switzerland GmbH!

Thoratec Switzerland GmbH is a proud part of the medical device division of Abbott Laboratories, a Fortune 500 company with over 115,000 employees worldwide. As the global market leader in implantable and extracorporeal blood pumps using advanced magnetic levitation technology, our innovative life-saving systems are developed and manufactured in Zurich, serving advanced heart failure patients in need of both short- and long-term circulatory support.

Located in the heart of Zurich, we employ around 130 individuals specializing in the development, quality, and production of the CentriMag system and the HeartMate 3. We are currently seeking a motivated and talented Senior Technical Specialist (Temporary, start date July 1, 2025 - until December 2026) to join our dynamic team.

Your Role

Become a part of a dedicated team responsible for establishing and maintaining processes throughout the entire supply chain and manufacturing life-supporting medical devices. Your efforts will help ensure that we meet the high standards of our industry, embodying our commitment to the principle of "built as intended for your family." In this role, you will collaborate with cross-functional teams in Switzerland and the USA.

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).
• Create and maintain validation documentation, including validation protocols, validation reports, and supporting documentation such as change orders, risk analysis, and deviation reports.
• Lead Test and Inspection Method Validation (TMV/IMV) activities.
• Support risk management activities, including updates to process Failure Mode and Effects Analysis (pFMEA)
• Assist in 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 (SCARs) and Supplier Change Requests (SCRs).
• Propose new or improved technologies and processes to enhance product quality, manufacturing efficiencies, and regulatory compliance.
• Drive continuous and measurable improvements in Operational Excellence (OPEX).
• Participate in internal and external audits as Subject Matter Expert (SME) for process validation.

The Profile

• Master’s degree or Bachelor's in Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a similar field (ETH/FH or comparable education).
• 10-12 years or more 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).
• Proven expertise in EU MDR regulations and cross-functional department coordination; leading MDR-related projects is a plus.
• Extensive experience in risk analysis (FMEA), process validation, and test method validation (TMV/IMV, IQ/OQ/PQ).
• Strong knowledge of statistical methods and software tools for data analysis, such as Minitab.
• Experience in manufacturing electronic or electromechanical products, as well as familiarity with SAP (ERP), Windchill (PLM), SolidWorks (CAD), and Power BI.
• Experience in EUMDR Class III and Class II medical devices submissions, obsolescence management, and various manufacturing processes (e.g., injection molding) is a plus.
• Strong project management capabilities to lead smaller projects independently.
• Fluency in English at Level C2 is required.
• A flexible team player with a meticulous approach to work and documentation.
• Excellent analytical and creative problem-solving abilities, along with process-oriented thinking.
• Proficiency in Microsoft applications (PowerPoint, Word, Excel, Visio).
• Experience in risk management activities according to ISO 14971:2019; certification is a plus.
• Minimum green belt Six Sigma certification; black belt is a plus.
• Prior experience at other Abbott plants will be considered an advantage.

Working at Abbott

At Abbott, you can engage in meaningful work that helps people live healthier, fuller lives. You'll have opportunities to grow your career and be your true self. Here’s what we offer:

• Career development within an international organization that prioritizes growth.
• A position in a Fortune 500 company and the world’s leading manufacturer of medical devices.
• A challenging role within a crisis-independent industry.
• Integration into a dynamic, highly educated, skilled, and motivated team.
• A multinational environment that promotes talent development within the enterprise.
• Competitive compensation and benefits package.
• A workplace in the vibrant heart of Zurich.

We are looking for highly motivated individuals eager to join our passionate team with broad responsibilities. If you have what it takes, please apply online using the form below. Please note that only applications matching the job profile will be considered.