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, support advanced heart failure patients requiring short- or long-term circulatory assistance.
Located in the heart of Zurich, our facility boasts a team of around 130 employees dedicated to the development, quality assurance, and production of the CentriMag system and the HeartMate 3. We are seeking a motivated and talented Senior Technical Specialist (Temporary, start date 1st July 2025 - until Dec 2026) to join our team.
Your Role
In this role, you will become part of a dedicated team responsible for establishing and maintaining processes throughout the supply chain and manufacturing of life-supporting medical devices utilizing the captivating technology of magnetic levitation. Your contributions will ensure our products and processes adhere to the elevated standards of our industry, aligned with our policy: “built as intended for your family.” This position will foster collaboration with cross-functional teams in Switzerland and the USA.
Main Responsibilities
- Accountable for process validation planning and execution, including supplier process validations (Master Validation Planning, Installation Qualification, Operational Qualification, Performance Qualification, Product Performance Qualification, and Supplier Process Validation).
- Creation and maintenance of validation documentation, including validation protocols, validation reports, and supporting documents like change orders, risk analyses, and deviation reports.
- Lead Test and Inspection Method Validation activities.
- Support risk management activities, such as updating process Failure Mode and Effects Analysis (pFMEA).
- Assist with CAPA or nonconforming material investigations and related validation activities.
- Engage closely with suppliers on manufacturing and quality issues, managing Supplier Corrective and Preventive Actions and Supplier Change Requests.
- Propose new or improved technologies and processes to enhance product quality, manufacturing efficiency, costs, 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 or Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a similar field.
- 10-12 years of experience in a similar role 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).
- Demonstrated expertise in EU MDR regulations and cross-functional department coordination.
- Proficient in risk analysis (FMEA) and process/test method validation.
- Strong understanding of statistical methods and analytical software tools, particularly Minitab.
- Background in manufacturing electronic or electromechanical products is a plus.
- Familiarity with SAP, Windchill, SolidWorks, and Power BI is advantageous.
- Experience in EUMDR Class III and Class II Medical device submissions and Obsolescence Management is a plus.
- Technical project management capabilities; ability to lead smaller projects independently.
- C2 level proficiency in English is required.
- Team-oriented with a meticulous approach to work and documentation.
- Excellent analytical, creative problem-solving, and process-oriented thinking skills.
- Proficient in Microsoft applications (PowerPoint, Word, Excel, Visio).
- Knowledge of risk management activities per ISO 14971:2019 is a plus; certification is desirable.
- Minimum Green Belt Six Sigma certification; Black Belt is a plus.
- Previous experience in other Abbott plants will be considered favorably.
Working at Abbott
At Abbott, you can engage in work that matters, help people lead healthier, fuller lives, grow your career, and truly be yourself. You'll have access to:
- Career development opportunities within an international company.
- A workplace in a Fortune 500 company and the leading global manufacturer of medical devices.
- A challenging position in a crisis-independent industry.
- A dynamic and highly skilled team.
- A multicultural environment that supports talent development.
- Competitive compensation and benefits.
- A location in the heart of Zurich.
We are looking for a highly motivated individual to join our passionate team with broad responsibilities. Do you have what it takes? Then apply online using the form below. Note that only applications matching the job profile will be considered. We look forward to welcoming you in the heart of Zurich!