Senior Process Engineer (Onsite)

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

Overview

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.

Overview

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 characterization (screening/optimization DOEs) to identify CTQs, establish control limits, and deliver capability, yield, and throughput targets.
• Develop, release, and maintain manufacturing documentation for transfer: process flow, PFMEA, control plan, work instructions, job aids, line layouts, routings/BOMs, and training materials.
• Own transfer readiness: plan engineering/pilot/PPQ builds, execute line trials, support ramp, and drive disciplined change control to closure.
• Lead investigations and disposition of development/transfer NCRs; generate effective CAPAs using root‑cause tools (e.g., 5‑Why, Fishbone, FMEA linkage) and verify effectiveness before launch.
• Implement MSA (gage R&R) and SPC; define data collection and dashboards; monitor early production performance and execute handoff to sustaining engineering.
• Partner with suppliers/CMOs to qualify new materials, tooling, and equipment; confirm capacity/capability, process controls, and incoming inspection plans; maintain supplier quality agreements.
• Translate design intent into robust, scalable processes via DFM; challenge tolerances/specs and influence design to improve manufacturability, yield, and COGS.
• Prepare and present phase‑/gate‑deliverables and technical reviews; ensure complete, audit‑ready DHF/DMR inputs and objective evidence.
• Ensure EHS readiness for new equipment/processes (risk assessments, ergonomics, machine guarding, LOTO) and verify resources are available and in safe working condition.
• Forecast and manage project schedules, budgets, and capital; create and execute equipment qualification plans, and coordinate installation.
• Provide hands‑on technical leadership and mentorship for junior engineers/technicians; may directly supervise personnel as business needs require.
• Communicate risks, dependencies, and decision tradeoffs proactively; maintain a visible risk register with mitigation/contingency plans and elevate early.
• Maintain compliance with Company policies and applicable regulations/standards across target markets; support internal/external audits with clear, data‑driven evidence.
• Perform other related duties and responsibilities as assigned.

Qualifications

Required Qualifications

Requires Engineering Bachelors Degree plus 5+ years of relevant experience.

Proven track record working within ISO 13485 and FDA‑regulated environments.

Experience with process/product validation, risk management (ISO 14971), design controls, and documentation practices.

Preferred Qualifications

• Excellent written and verbal communication and interpersonal skills
• Must have the ability to manage work to meet tight timelines and budgetary guidelines
• Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
• Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
• Work includes potential exposure to chemicals.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.