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.
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 – test and validate 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.
Education & Qualifications
Degree qualified in relevant engineering or scientific discipline and/or proven experience working as an engineer within a regulated industry.
Key Skills & Experience
* 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.
Roche is an Equal Opportunity Employer.
#J-18808-Ljbffr