Manufacturing/Validation Engineer
About The Position
Lead the qualification of production equipment and the validation of manufacturing processes in a regulated medical-device environment. Create URS and FMEA documentation, execute risk-based IQ/OQ/PQ/SQ, support CAPA/NCRs, manage cross-functional projects, drive CI/Six Sigma improvements, write SOPs, and train production staff—ensuring compliance with 21 CFR Part 820, 21 CFR Part 11, and ISO 13485. Role Description Equipment Qualification & Process Validation: Develop URS, conduct risk assessments, plan/execute IQ/OQ/PQ/SQ, manage deviations, and produce audit-ready reports. CAPA/NCR Support: Lead/participate in root-cause investigations, define corrective/preventive actions, verify effectiveness, and maintain clear documentation Project Management: Build schedules and budgets, coordinate vendors, track risks/issues, and report status to stakeholders through stage-gate milestones. CI / Six Sigma: Apply DMAIC, PFMEA, SPC/CPK, MSA/Gage R&R, and DOE to reduce waste, improve yield/throughput, and sustain process capability. SOP & Document Control: Author and revise SOPs, work instructions, forms, and validation documentation under change control; maintain inspection-ready files. Training & Enablement: Develop training materials; coach technicians and operators on new equipment, validated processes, and documentation standards. Compliance & Readiness: Support internal/external audits; ensure Part 11 data integrity (ALCOA+) for computerized/automated systems.
Requirements
- B.S. in Mechanical, Electrical, Chemical, Biomedical, Industrial or related engineering field.
- 4+ years in medical device (or similarly regulated) manufacturing.
- Hands-on ownership of URS, FMEA, and IQ/OQ/PQ/SQ deliverables for equipment and processes.
- Experience supporting CAPA/NCR lifecycle
- Working knowledge of 21 CFR 820, 21 CFR Part 11, ISO 13485
- Strong technical writing and cross-functional communication; solid project coordination skills.
Nice To Haves
- Exposure to automation/MES/SCADA/PLC, data acquisition, or vision/inspection systems.
- Proficiency with Lean/Six Sigma methods (5S, VSM, SPC, DOE, MSA); Six Sigma Green Belt preferred.
- Tools: Agile PLM, MS Project/Smartsheet; basic SQL/Power BI a plus.
- Certifications: PMP
Responsibilities
- Lead the qualification of production equipment and the validation of manufacturing processes in a regulated medical-device environment.
- Create URS and FMEA documentation
- Execute risk-based IQ/OQ/PQ/SQ
- Support CAPA/NCRs
- Manage cross-functional projects
- Drive CI/Six Sigma improvements
- Write SOPs
- Train production staff
- Develop URS
- Conduct risk assessments
- Plan/execute IQ/OQ/PQ/SQ
- Manage deviations
- Produce audit-ready reports
- Lead/participate in root-cause investigations
- Define corrective/preventive actions
- Verify effectiveness
- Maintain clear documentation
- Build schedules and budgets
- Coordinate vendors
- Track risks/issues
- Report status to stakeholders through stage-gate milestones.
- Apply DMAIC, PFMEA, SPC/CPK, MSA/Gage R&R, and DOE to reduce waste, improve yield/throughput, and sustain process capability.
- Author and revise SOPs, work instructions, forms, and validation documentation under change control; maintain inspection-ready files.
- Develop training materials
- Coach technicians and operators on new equipment, validated processes, and documentation standards.
- Support internal/external audits
- Ensure Part 11 data integrity (ALCOA+) for computerized/automated systems.
Benefits
- eligibility for bonus
- stock
- benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
