Project Engineer
Overview
EPM is seeking a Project Engineer / Senior Manufacturing Engineer to lead and execute manufacturing engineering initiatives for our global medical device partner focusing on Class III implantable cardiac devices (e.g. pacemakers, ICDs) on a freelance basis for 12 months, 40 hours per week.
This is a hands-on, delivery-focused role with ownership of process development, validation, and manufacturing scale-up, while also acting as a project lead across cross-functional teams.
Key Responsibilities
Manufacturing Engineering & Execution
- Lead development, optimisation, and transfer of manufacturing processes for implantable electronic devices
- Execute process validation activities (IQ/OQ/PQ) and ensure robust documentation
- Troubleshoot manufacturing issues, drive yield improvements, scrap reduction, and process capability
- Support equipment qualification, FAT/SAT, and line commissioning
- Drive DFM/DFA alignment between R&D and manufacturing
Project Ownership
- Own workstreams or full project delivery for NPI, tech transfer, or remediation activities
- Develop and track project timelines, deliverables, and risks
- Coordinate cross-functional stakeholders (Quality, Regulatory, R&D, Supply Chain, Operations)
- Provide clear updates on progress, constraints, and mitigation plans
Validation & Regulatory Compliance
- Lead execution of validation strategies in line with:
- ISO 13485 / FDA QSR (21 CFR Part 820)
- Generate and review:
- Validation protocols and reports
- Risk assessments (FMEA, process risk)
- Ensure compliance with QMS, change control, and audit requirements
Contract Criteria
- 12 Month Initial Engagement
- 40 Hours Per Week
- 100% on-site (Southern Germany)
- Paid on flexible hourly rate
Required Experience
- 5-10+ years in manufacturing engineering within medical devices
- Strong experience with Class II/III devices (implantables preferred)
- Proven hands-on expertise in:
- Process validation (IQ/OQ/PQ)
- Manufacturing process troubleshooting and optimisation
- Experience working within:
- ISO 13485 / FDA / GMP environments
- Demonstrated ownership of projects or workstreams within NPI / transfer / scale-up
- Degree in:
- Mechanical, Electrical, Biomedical, or Manufacturing Engineering (or equivalent)
Key Competencies
- Strong hands-on problem solving
- Ability to combine engineering execution with project ownership
- Excellent cross-functional communication
- Comfortable in fast-paced, highly regulated environments
FAQs
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