Abbott
Our Zurich Site Employs More Than 100 People, Covering Areas Including R&D And Manufacturing. Currently, We Are Expanding Our Innovative And High-caliber Manufacturing Engineering Team In Zurich And An Exciting Opportunity Exists For a Motivated And Talented
Senior Manufacturing Engineer
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
- 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)
- Creation and maintenance of validation documentation, e.g. validation protocols, validation reports and supporting documentation such as change orders, risk analysis, deviation reports, etc.
- Lead Test and Inspection Method Validation activities (TMV/IMV) Support risk management activities such as process Failure Mode and Effects Analysis updates (pFMEA’s)
- Support 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 (SCAR’s) and Supplier Change Requests (SCR’s)
- Propose new or improved technologies and processes to enhance product quality, manufacturing efficiencies, cost, and regulatory compliance
- Drive continuous and measurable improvements OPEX (Operational Excellence)
- Participate in internal and external audits as SME for process validation
The Profile
- Master’s Degree in Electrical Engineering, Mechanical Engineering, Computer Science or similar (ETH/FH or comparable education)
- 8- 10 years of experience in a similar position in Med-Tech industry Detailed knowledge of medical standards like ISO 13485, FDA 21CFR820, ISO 14971, MDR, GMP, GDP, IMRDF (GHTF)
- Proven expertise in risk analysis (FMEA), process and test method validation (TMV/IMV, IQ/OQ/PQ(PPQ)
- Detailed knowledge of statistical methods, techniques, and software tools to analyze data such as Minitab
- Experience in manufacturing of electronic products is a plus Knowledge of SAP (ERP system), Windchill (PLM and Change Order system), Solid Works (CAD) is a plus
- English Level C2 is required, German would be a plus
- Flexible team player with accurate working and documentation style
- Excellent analytical and creative problem-solving skills and process thinking
- Proficient in Microsoft applications (Powerpoint, Word, Excel, Visio)
- Minimum green belt six sigma certification
What We Offer
- A workplace in a frontline fortune 500 company and the world’s leading manufacturer of LVAD’s
- A challenging position in a fast-growing crisis independent industry
- To become part of a dynamic, highly educated, highly skilled, and motivated team Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
- Multi-national environment, where we foster the development of our talents within the enterprise
- Competitive compensations and benefits
- A workplace in the center of Zurich with R&D and manufacturing under one roof
Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your full application online in pdf format.
To apply for this job please visit www.jobs.abbott.