Process Engineer
Freelance Process Engineer (Medical Devices) - 6 to 12 Months
Location: Germany (On-site or Hybrid)
Contract Type: Freelance
Duration: 6-12 months
Languages Required: Fluent in German and English
About the Role
We are seeking an experienced Freelance Process Engineer to support our medical device manufacturing operations in Germany. This role is focused on optimizing production processes, ensuring regulatory compliance, and supporting scale-up activities for Class II and III medical devices.
Key Responsibilities
- Design, analyze, and optimize manufacturing processes for medical devices
- Lead process validation activities (IQ/OQ/PQ) in accordance with ISO 13485 and FDA 21 CFR Part 820
- Collaborate with cross-functional teams including Quality, R&D, and Manufacturing
- Troubleshoot production issues and implement corrective and preventive actions (CAPA)
- Support documentation efforts including SOPs, work instructions, and validation protocols
- Drive continuous improvement initiatives using Lean and Six Sigma methodologies
Requirements
- Degree in Mechanical, Biomedical, or Process Engineering (or related field)
- Minimum 3 years of experience in medical device manufacturing
- Proven expertise in process validation and regulatory compliance
- Strong knowledge of GMP, ISO 13485, and FDA regulations
- Proficiency in tools such as Minitab, SolidWorks, or similar
- Fluent in German and English (written and spoken)
- Strong problem-solving and communication skills
Preferred Qualifications
- Experience with cleanroom manufacturing
- Familiarity with automation and digital manufacturing tools
- Six Sigma Green or Black Belt certification
What We Offer
- Competitive freelance rates
- Flexible working arrangements (on-site or hybrid)
- Opportunity to work with a leading medical device manufacturer
- Dynamic and collaborative work environment
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