OverviewThis 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 escalate 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.
QualificationsRequired 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.
