Cordis · 1 month ago
Senior Process Engineer (Onsite)
Miami Lakes, FL
Full-time
Onsite
Senior Level
5+ years expCordis is a global leader in cardiovascular and endovascular technology, dedicated to transforming cardiovascular care. The Senior Process Engineer will partner with internal teams and suppliers to drive new products and manufacturing processes from design through commercialization, ensuring compliant and scalable production.
Health CareHealth DiagnosticsMedical
Responsibilities
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
Qualification
Required
Requires Engineering Bachelors Degree plus 5+ years of relevant experience
Preferred
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
Excellent written and verbal communication and interpersonal skills
Must have the ability to manage work to meet tight timelines and budgetary guidelines
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
H1B Sponsorship
Cordis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
Company data provided by crunchbase