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The Position

Purpose:

LumiraDx sensors are complex, highly regulated products that require precision manufacturing, supported by a detailed supply chain, and monitored closely for on-market issues.

The product care engineer will support the manufacturing, logistics, R&D, and quality teams with material lifecycle management, on-market product support, and transfer of new products to manufacturing.

Product or material issues are reviewed through the operations Action Team. Engineering resources are assigned to contain and troubleshoot problems, using a structured and methodical approach. Communication is key, and the product care engineer will report progress to the Action Team and other management stakeholders.

Responsibilities:

• Technical supplier management – Work with cross-functional teams across sensor manufacturing and packaging to manage and support material lifecycles as LumiraDx transfers products to Roche branding and IVDR registration.

• On-market product support – Join the Action Team and perform root-cause investigations into product performance and manufacturing issues. Support material change projects by testing and validating changes from suppliers.

• Product design transfers – Aid the design transfer teams by developing and validating manufacturing processes for new products. Characterise product attributes and processes through DOE and test method development.

Profile:

Essential Education/ Qualifications:

• Degree qualified in relevant engineering or scientific discipline and/or proven experience working as an engineer within a regulated industry

Requirements (incl. Key Skills):

• Hands-on engineer with experience in medical (or other regulated) industry

• Experience working in a fast-paced, target driven and regulated environment.

• Experience working on multiple projects in tandem, while meeting timelines.

• Experience / awareness of equipment, product, and process development and optimisation.

• Experience with, or willingness to learn, the use of metrology equipment to assess and characterise products and materials.

• Knowledge of statistical process controls, capabilities, and analysis techniques.

• Experience of writing and executing product and process verification protocols.

• High level of computer literacy in MS Office.

• Competent in documentation and report writing, specifically verification and validation protocols and reports.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.