Senior Process Engineer (Onsite)

About the role

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care. At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

Responsibilities

• This role partners with internal development teams and third‑party suppliers/CMOs to drive new products and manufacturing processes from late design through commercialization.
• The engineer owns process characterization and validation—bringing up equipment and executing IQ/OQ/PQ—alongside test method development/validation to ensure compliant, scalable, and reliable production.
• They coordinate cross‑functional timelines, remove roadblocks, and de‑risk transfers into internal plants or qualified contract manufacturers.
• Using data‑driven tools (e.g., DOE, capability analyses, SPC), they design robust processes and control strategies that achieve high yields and consistent throughput.
• As the technical bridge between R&D and Operations, they secure launch readiness and long‑term manufacturability across the supply network.
• Lead NPI/tech‑transfer projects from late design through commercial launch, coordinating R&D, Quality/Regulatory, Operations, and external CMOs/suppliers to meet development timelines and readiness gates.
• Define manufacturing strategy (make/buy, site selection) and equipment/process requirements; support vendor selection, and manage FAT/SAT for new equipment through site acceptance and release.
• Plan, author, and execute process/equipment validation (IQ/OQ/PQ) and test method validation (TMV) per 21 CFR 820, ISO 13485, and ISO 14971; set sampling plans and acceptance criteria.
• Design and run structured process