Senior Process Engineer - NPI & Validation Lead

Cordis; Town of Florida (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Cordis is seeking an experienced hardware/medical device manufacturing engineer to lead NPIs and transfer activities from late design to commercial launch. You will coordinate R&D, Quality/Regulatory, Operations, and external CMOs to ensure readiness and robust processes.

The role requires hands‑on validation, process characterization, and the development of PFMEA, control plans, and training materials. Strong knowledge of ISO 13485 and FDA guidelines is essential.

Qualifications

• Engineering degree with 5+ years of relevant experience.
• Experience in ISO 13485 and FDA‑regulated environments.
• Experience with process/product validation, risk management (ISO 14971), design controls, and documentation practices.

Responsibilities

• Lead NP I/tech‑transfer projects from late design through commercial launch, coordinating cross‑functional teams.
• Define manufacturing strategy and equipment/process requirements; support vendor selection and manage FAT/SAT for new equipment.
• Plan, author, and execute process/equipment validation (IQ/OQ/PQ) and TMV per 21 CFR 820, ISO 13485, ISO 14971.
• Design structured process characterization (DOEs) to identify CTQs, establish control limits, and deliver capability and throughput targets.
• Develop, release, and maintain manufacturing documentation for transfer (DHF/DMR, PFMEA, control plans, routings, work instructions).
• Own transfer readiness: plan engineering/pilot/PPQ builds, execute line trials, and drive change control to closure.
• Lead investigations and disposition of NCRs; generate CAPAs and verify effectiveness before launch.
• Implement MSA and SPC; monitor early production performance and hand off to sustaining engineering.
• Qualify new materials, tooling, and equipment with suppliers/CMOs; confirm capacity and inspection plans.
• Translate design intent into robust, scalable processes via DFM; influence design for manufacturability and cost.

Skills

Communication skills

Project management

Validation & risk management

Design controls

Documentation practices

Education

Engineering Bachelor's Degree

Job description

Cordis is seeking an experienced hardware/medical device manufacturing engineer to lead NPIs and transfer activities from late design to commercial launch. You will coordinate R&D, Quality/Regulatory, Operations, and external CMOs to ensure readiness and robust processes.

The role requires hands‑on validation, process characterization, and the development of PFMEA, control plans, and training materials. Strong knowledge of ISO 13485 and FDA guidelines is essential.