Project Engineer

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