Packaging Engineer

EPM Scientific; Baden-Württemberg; Vor Ort; EUR 60.000 - 80.000; Teilzeit

Zusammenfassung

A leading company in the medical device industry is seeking a skilled Packaging Engineer for a freelance role focused on developing and validating packaging solutions for Class III medical devices. The ideal candidate will have hands-on experience in packaging design and regulatory compliance and be ready to contribute to critical projects.

Qualifikationen

• 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 ISO 13485 and FDA regulations.

Aufgaben

• Design, develop, and validate packaging systems for Class III medical devices.
• Conduct packaging testing and support documentation for regulatory submissions.
• Collaborate with cross-functional teams to ensure compliance with standards.

Kenntnisse

Packaging design

Testing

Regulatory compliance

Packaging materials knowledge

Communication skills in German

Jobbeschreibung

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