Position:

Medical Device Development Lead

Level:

Mid - Senior

Type:

Internal, Full-time

Location:

Austria or Spain (work permit provided for non-EU employees, must be willing to relocate)

Job description:

This is a full-time role for a Medical Device Development Lead with flexible location based in Austria or Spain. The position will offer the opportunity to work with a integral cross‑functional team, supporting medical device design stage initiatives while gaining exposure to various technologies. The role will involve in-person and/or remote collaboration as needed according to assigned projects.

The Medical Device Development Lead will own and contribute to comprehensive design initiatives across the full product life cycle.

Main Responsibilities:

-
- Drive device development projects across all design stages, collaborating with subject matter experts to complete deliverables following applicable Design Controls.
- Author key Design History File documents (DIR, Design V&V; reports, etc.) and complete phase reviews.




- Draft or collaborate on applicable Risk Management and Human Factors documentation, improving product design and user interactions (RM Plan, FMEA, URRA, Task/Comparative Analysis, etc.).
- Ensure that medical device RM and Usability considerations are documented according to applicable standards (e.g., ISO 14971, IEC 62366).
- Collaborate with manufacturers as technical lead, planning assemblies required for testing, clinical trial, or commercial production.
- Support Post-Market Surveillance activities and determine necessary updates to product design, Risk File, and Usability based on collected feedback.
- Support Regulatory Affairs in preparing medical device submissions (e.g., US FDA 510(k), EU Technical Documentation for CE marking, etc.). Support during audits, inspections, and Health Authority reviews to address deficiencies or additional information requests.
- Work with common word processing, spreadsheet, and collaborative tools (e

📌 Pharmaceutical Development Lead (España)
🏢 Suma Medtec
📍 España