Medical Device Development Lead — Hybrid (Tyrol)

Suma Medtec GmbH; Kufstein; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

5 weeks vacation

Health insurance

Career development

Work‑life balance

Job summary

Suma Medtec GmbH seeks a Medical Device Development Lead in Austria’s Tyrol region to drive design initiatives across the full product life cycle with emphasis on device technology, risk management and usability.

The candidate will join a global cross‑functional team and contribute to design controls, DHF documentation, and regulatory submissions. Hybrid in‑person and remote collaboration is required.

Qualifications

• BS, MS or PhD in Engineering or health‑related field.
• Minimum of 2 years industry experience in medical device or pharmaceutical sectors.
• Experience with cross‑functional teams and DHF documentation (R&D, RM, HFE, QA, RA, Clinical).
• Fluent English reading/writing; remote work capable; willingness to relocate if needed.

Responsibilities

• Support device development across all design stages following Design Controls.
• Author DHF documents (DIR, V&V reports, Risk File).
• Draft Risk Management and Human Factors documentation (RM Plan, FMEA, URRA).
• Ensure RM and Usability considered per ISO 14971 and IEC 62366.
• Collaborate with manufacturers as technical lead for testing and production.
• Support Post‑Market Surveillance and regulatory submissions (FDA, CE, MDR).
• Communicate via MS Office tools and meetings.

Skills

English proficiency

Education

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

Tools

Microsoft Office

Job description

Suma Medtec GmbH seeks a Medical Device Development Lead in Austria’s Tyrol region to drive design initiatives across the full product life cycle with emphasis on device technology, risk management and usability.

The candidate will join a global cross‑functional team and contribute to design controls, DHF documentation, and regulatory submissions. Hybrid in‑person and remote collaboration is required.