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 If you have the required experience and are interested in supporting a high-impact Class III device programme, please apply now.