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Packaging engineer

Baden-Baden
EPM Scientific
Ingenieur
Inserat online seit: 26 Juli
Beschreibung

Job Title: Packaging Engineer - Medical Devices Location: Germany (On-Site) Contract Type: Freelance / Contract Duration: 12 months (with potential extension) Start Date: ASAP About the Role: We are seeking a highly skilled Packaging Engineer to support the development and validation of packaging solutions for Class III medical devices. This freelance role is ideal for an engineer with hands-on experience in packaging design, testing, and regulatory compliance-particularly within surgical devices, lab automation systems, or imaging technologies. Important Requirements: Must have prior experience in the medical device industry. Applications without this experience will not be considered. Must have the right to work in Germany. Visa sponsorship is not available for this role. Key Responsibilities: Design, develop, and validate packaging systems for Class III medical devices in compliance with ISO 11607 and other applicable standards Collaborate with cross-functional teams including R&D, manufacturing, and quality to ensure packaging meets product, user, and regulatory requirements Conduct packaging testing (e.g., transit, shelf-life, and sterile barrier integrity) and support documentation for regulatory submissions (e.g., CE marking, FDA) Support packaging process development, scale-up, and technology transfer to manufacturing Contribute to risk assessments, design reviews, and continuous improvement initiatives Essential Skills & Experience: 5 years of experience in packaging engineering within the medical device or life sciences industry Proven experience with medical devices and sterile packaging systems Strong understanding of packaging materials, sealing technologies, and validation protocols Experience with surgical instruments, lab automation systems, or diagnostic imaging products Familiarity with agile development environments and international project coordination Knowledge of EU MDR, FDA 21 CFR Part 820, and ISO 13485 Excellent communication skills in German (required); English is a plus

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