Senior Technical Specialist

Thoratec Switzerland GmbH

Publication date:
23 May 2025
Workload:
100%
Contract type:
Permanent position
Place of work:Zurich

Job summary

Join Thoratec Switzerland GmbH, a leader in medical devices. Work in Zurich with a talented team to innovate life-saving technologies.

Tasks

Oversee process validation planning and execution for medical devices.
Maintain documentation for validations and related activities.
Collaborate with suppliers on quality and manufacturing topics.

Skills

Master’s in engineering with 10-12 years in Med-Tech.
Expertise in ISO standards and medical regulations required.
Strong analytical skills and experience with statistical tools needed.

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<div>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 for implantable and extracorporeal blood pumps based on magnetic levitation technology. Our life-saving systems, which we develop and manufacture in Zurich, are used for advanced heart failure patients needing short- or long-term circulatory support.Our location in the heart of the city of Zurich has around 130 employees in the areas of development, quality and production of the CentriMag system and the HeartMate 3. We are looking for a motivated and talentedSenior Technical Specialist (Temporary, start date 1st July 2025- until Dec 2026 - ) to join our team.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<ul><li>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)</li><li>Creation and maintenance of validation documentation, e.g. validation protocols, validation reports and supporting documentation such as change orders, risk analysis, deviation reports, etc.</li><li>Lead Test and Inspection Method Validation activities (TMV/IMV) Support risk management activities such as process Failure Mode and Effects Analysis updates (pFMEA’s)</li><li>Support CAPA or nonconforming material (NCMR) related investigation or validation activities</li><li>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)</li><li>Propose new or improved technologies and processes to enhance product quality, manufacturing efficiencies, cost, and regulatory compliance</li><li>Drive continuous and measurable improvements OPEX (Operational Excellence)</li><li>Participate in internal and external audits as SME for process validation</li></ul>THE PROFILE<ul><li>Master’s degree/bachelor’s in electrical engineering, Mechanical Engineering, Industrial Engineering or similar (ETH/FH or comparable education)</li><li>10- 12 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)</li><li>Proven expertise in EU MDR regulations and cross-functional department coordination. Leading MDR-related projects will be considered a plus.</li><li>Proven expertise in risk analysis (FMEA), process and test method validation (TMV/IMV, IQ/OQ/PQ)</li><li>Detailed knowledge of statistical methods, techniques, and software tools to analyze data such as Minitab</li><li>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</li><li>Experience in EUMDR Class III and Class II Medical devices submissions, Obsolescence Management and Various Manufacturing Process (Injection molding) considered a plus</li><li>Technical Project Management: Ability to lead smaller Project independently</li><li>English Level C2 is required</li><li>Flexible team player with accurate working and documentation style</li><li>Excellent analytical and creative problem-solving skills and process thinking</li><li>Proficient in Microsoft applications (PowerPoint, Word, Excel, Visio)</li><li>Risk management activities according to ISO 14971:2019, certification is a plus</li><li>Minimum green belt six sigma certification, black belt is a plus</li><li> Previous experience in other Abbott’s plants will be considered a plus</li></ul>Working at Abbott At Abbott, you can do work that matters and help people to live a healthier and fuller life, grow your career, and learn, be your true self. You will have access to: <ul><li>Career development with an international company where you can grow </li><li>A workplace in a fortune 500 company and the world’s leading manufacturer of medical devices </li><li>A challenging position in a crisis independent industry </li><li>To become part of a dynamic, highly educated, highly skilled, and motivated team </li><li>Multi-national environment, where we foster the development of our talents within the enterprise </li><li>Competitive compensations and benefits </li><li>A workplace in the heart of Zurich </li></ul>We are looking for highly motivated person who would like to be part of our passionate team with broad responsibilities. Do you have what it takes? Then send us your application including motivation letter, curriculum vitae, letter of recommendation and diplomas today. We are looking forward to meeting you in the heart of Zurich! Please follow our Career site and check for available openings: <a href="https://www.jobs.abbott/us/en" target="_blank">Abbott Jobs | Apply Now | Abbott Laboratories Careers</a> </div>

Senior Technical Specialist

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