R&D Responsibilities

• Participate in process design and verification/validation for related products.
• Prepare operational instructions, technical drawings, and product quality requirements.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new equipment.
• Troubleshoot equipment and tooling issues, along with performing basic maintenance as needed.
• Transfer technical documentation, including Device Master Records (DMR) and Design History Files (DHF).

Project Responsibilities

• Serve as the primary contact and manage the entire process of transferring product production knowledge between facilities.
• Collaborate with cross-functional teams to drive projects and ensure adherence to timelines.
• Oversee project planning and progress control to facilitate smooth and successful transitions.
• Supervise the setup of local production lines, ensuring compliance with quality and efficiency standards.
• Ensure readiness of capabilities and proper transfer of project-related knowledge and technology.

Qualifications

• Bachelor’s degree or higher in Engineering, Materials Science, Mechanical Engineering, or a related field.
• Minimum of 5 years of experience in the Class III Medical Device industry, with a preference for experience in balloon products.
• Strong project management experience, with Project Management Professional (PMP) certification preferred.
• Demonstrated experience in product manufacturing transfers.
• Proficient in Microsoft Office and CAD software such as SolidWorks or Creo.
• Familiarity with FDA and CE regulatory requirements.
• Proficiency in German and Mandarin, both spoken and written, is essential; English proficiency is a plus.

Job Type: Full-time
Pay: 4.000,00€ - 6.000,00€ per month

Ability to commute/relocate:

• 79576 Weil am Rhein, Germany: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

• Are you proficient in SolidWorks or Creo?
• What is your familiarity with FDA and CE regulatory requirements?

Education:

• Bachelor’s (Preferred)

Experience:

• Class III Medical Device: 5 years (Preferred)

Language:

• German (Preferred)
• Mandarin (Preferred)

License/Certification:

• Project Management Professional (PMP) certification (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: In perso

R&D Responsibilities

• Participate in process design and verification/validation for related products.
• Prepare operational instructions, technical drawings, and product quality requirements.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new equipment.
• Troubleshoot equipment and tooling issues, along with performing basic maintenance as needed.
• Transfer technical documentation, including Device Master Records (DMR) and Design History Files (DHF)

Project Responsibilities

• Serve as the primary contact and manage the entire process of transferring product production knowledge between facilities.
• Collaborate with cross-functional teams to drive projects and ensure adherence to timelines.
• Oversee project planning and progress control to facilitate smooth and successful transitions.
• Supervise the setup of local production lines, ensuring compliance with quality and efficiency standards.
• Ensure readiness of capabilities and proper transfer of project-related knowledge and technology