Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are based here. For our long-standing client, Roche Diagnostics International AG in Rotkreuz, we are looking for a:
At Roche Diagnostics, we develop and deliver life-critical diagnostic solutions that support healthcare professionals and patients worldwide.
As part of the Manufacturing Science and Technology (MSAT) organization within the Global Instrument Network (GIN), you will play a key role in ensuring robust manufacturing processes, reliable supplier performance, and long-term supply security.
You will act as the technical interface between internal engineering and operations teams and international contract manufacturing partners. Your responsibilities include technical ownership of instrument components, subassemblies, and production lines, with a strong focus on manufacturing process design, validation, and industrialization.
You will also lead external-to-external (E2E) technology transfers, second-sourcing initiatives, and capacity expansions to ensure consistent product quality and reliable supply.
Your Responsibilities
Design, develop, optimize, and industrialize manufacturing and testing processes for instrument components, electronics, and precision assemblies across external supplier sites.
Define and implement process validation strategies (IQ/OQ/PQ), design verification protocols, and process capability assessments, including Cp/Cpk, tolerance studies, and Gage R&R.
Collaborate with R&D during early product development to integrate Design for Manufacturing, Assembly, and Testability (DfX) principles, improve yields, and prevent manufacturing bottlenecks.
Identify and mitigate manufacturing risks through pFMEA, poka-yoke (error-proofing), and structured root-cause investigations.
Lead external-to-external (E2E) technology transfers between contract manufacturers and suppliers, including production line relocations, tool duplications, and second-source qualifications.
Develop qualification master plans (QMPs), coordinate project schedules and milestones, and provide transparent progress reporting to MSAT and GIN leadership.
Ensure technical alignment and effective change control between transferring and receiving supplier sites, Roche Global Sourcing, Quality Assurance, and Regulatory Affairs.
Your Profile
University degree (Bachelor's or Master's) or Higher Technical Diploma in Mechanical Engineering, Electrical Engineering, Mechatronics, Process Engineering, Industrial Engineering, or a related technical discipline.
At least 5–6 years of relevant industry experience in manufacturing process design, technical supplier management, industrialization, or manufacturing engineering, ideally within medical devices, in-vitro diagnostics (IVD), pharmaceuticals, or precision high-tech equipment.
Proven hands-on experience in designing, qualifying, and optimizing manufacturing and testing processes.
Strong knowledge of statistical process control (SPC), process capability studies (Cp/Cpk), measurement systems analysis (MSA), and pFMEA.
Solid understanding of precision manufacturing technologies, such as injection molding, precision mechanics and machining, electronics assembly, and automated testing.
Understanding of manufacturing cost drivers and cycle time optimization.
Practical knowledge of ISO 13485, GMP/FDA regulations, process validation (IQ/OQ/PQ), and formal change management procedures.
Demonstrated experience leading complex technical projects, particularly external-to-external technology transfers, second-sourcing initiatives, or major production line ramp-ups.
A project management certification (PMP, IPMA, Agile) is an advantage.
Pragmatic and innovative problem-solving skills, with the ability to think outside the box.
Strong communication skills and the ability to collaborate effectively with international and cross-functional stakeholders.
Please send your complete application documents to Ms Nadine Rutz.
Chemistry, Pharmaceuticals, Pharmacy, Diagnostics, Zug, Lucerne, Full-time, Strategic, Lead, Manager