Freelance Manufacturing Engineer
Freelance Manufacturing Engineering Lead
Location: Munich, Germany (onsite / hybrid depending on site)
Contract: Freelance / Interim
Duration: 6-12 months (extension likely)
Start: ASAP
Overview
We are supporting a leading medical device manufacturer in Germany seeking an experienced Manufacturing Engineering Lead to drive operational performance, process optimisation, and technology initiatives across a high-volume production environment.
This role sits at the intersection of engineering and manufacturing operations, focusing on improving efficiency, scaling production, and ensuring regulatory-compliant processes.
Key Responsibilities
- Lead and optimise end-to-end manufacturing processes, including injection moulding, assembly, and cleanroom production
- Drive process engineering improvements using Lean Six Sigma methodologies and data-led decision making
- Monitor and improve KPIs such as OEE, yield, scrap rate, and throughput
- Support industrialisation and scale-up of new and existing products into manufacturing
- Deliver continuous improvement initiatives (CIP), identifying cost-saving and efficiency gains
- Collaborate cross-functionally with Production, Quality, R&D, and Maintenance teams
- Ensure compliance with ISO 13485, GMP, and FDA regulations within a regulated environment
- Lead or support automation and digitalisation projects (Industry 4.0, IoT integration)
- Manage process validation and technical documentation where required
- Support layout optimisation, capacity planning, and equipment investment projects
Required Experience
- Proven experience in manufacturing engineering within medical devices, pharma, or highly regulated industries
- Strong expertise in process optimisation, Lean Manufacturing, and continuous improvement
- Experience working with KPIs (OEE, yield, scrap, throughput) and data-driven performance management
- Hands-on experience with production environments (e.g. cleanroom, plastics, electronics, or similar)
- Solid understanding of ISO 13485 / GMP / FDA regulations
- Experience supporting technology transfer, production scale-up, or process industrialisation
- Strong stakeholder management across engineering, operations, and quality
Desirable
- Experience with automation, digitalisation, or Industry 4.0 initiatives
- Background in injection moulding, plastics manufacturing, or semiconductor/electronics production
- Prior experience in interim / freelance assignments
- Knowledge of process validation (IQ/OQ/PQ)
Key Competencies
- Strong analytical and problem-solving skills with a data-driven mindset
- Ability to drive change and operational improvements in complex environments
- Confident working in cross-functional, international teams
- Pragmatic, hands-on approach with a focus on delivery and measurable impact
This role will play a key role in optimising and scaling a regulated manufacturing opeartions.
If this is of interest to you and you have the necessary experience to hit the ground running in this project, please do not hesitate to apply.
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