Medical Device Development Lead (Hybrid) - Tyrol

Suma Medtec; Kufstein; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

5 weeks vacation + local holidays

Health insurance

Competitive salary/bonus

Career development opportunities

Collaborative team environment

Job summary

Suma Medtec GmbH seeks a Medical Device Development Manager in Austria's Tyrol region. The role blends in-person and remote work, leading design initiatives across the product life cycle and collaborating with global teams on device development, risk management, and usability.

Ideal candidates will have 2+ years in medical devices or pharma, strong English, and experience with regulatory submissions and cross-functional DHF documentation. Relocation may be required.

Qualifications

• This role requires a BS, MS, or PhD in Engineering or health-related field.
• Minimum of 2 years industry experience in medical devices or pharma.
• Experience with cross-functional teams and DHF documentation.
• Familiarity with global regulatory requirements (FDA, CE Marking, ISO 13485, MDR).
• English language proficiency (reading/writing) is essential.

Responsibilities

• Support device development projects across all design stages following Design Controls.
• Author DHF documents (DIR, Design V&V, Risk File) for phase reviews.
• Draft Risk Management and Human Factors documentation (RM Plan, FMEA, URRA) to improve design and usability.
• Ensure RM and Usability documentation complies with ISO 14971 and IEC 62366.
• Collaborate with manufacturers as technical lead for testing and production.
• Support Post-Market Surveillance and implement design updates based on feedback.
• Assist Regulatory Affairs with submissions (FDA 510(k), EU Technical Documentation).
• Communicate effectively via MS Office and participate in meetings.

Skills

Self-directed

Interpersonal skills

Decision making

Communication skills

Presentation

Team collaboration

Education

BS/MS/PhD in Engineering or health-related field

Tools

Microsoft Office

Job description

Suma Medtec GmbH seeks a Medical Device Development Manager in Austria's Tyrol region. The role blends in-person and remote work, leading design initiatives across the product life cycle and collaborating with global teams on device development, risk management, and usability.

Ideal candidates will have 2+ years in medical devices or pharma, strong English, and experience with regulatory submissions and cross-functional DHF documentation. Relocation may be required.