Medical Device Development Lead

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 global 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.g., Microsoft Office), and communicate effectively through presentations and online/in-person meetings.

Candidate profile and required qualifications:

• Relevant Experience: a minimum of 5 years (8 years for Senior level) within the medical device or pharmaceutical industry is required (e.g., developing medical devices, SaMD, combination products, IVDs).
• Studies: BS, MS, or PhD. in Engineering or health-related field.
• Experience working with cross-functional teams in medical device development from concept to market launch. Prior experience as a subject matter expert responsible for DHF documentation (e.g. R&D, RM, HFE, QA, RA, Clinical).
• Self-directed, works independently in a remote setting and as part of a team.
• Demonstrates excellent interpersonal skills, working with diverse groups of people in a global arena.
• Ability to drive decisions, promote progress, and manage multiple projects.
• Offers strategic and practical solutions to development team, presenting findings in concise and clear manner.
• Familiarity with global regulatory requirements (FDA, CE Marking, ISO 13485, MDR, etc.). Experience with HA submission preparation is a plus.
• Interested in gaining experience in multiple key roles of medical device development, across various technologies.
• Experience in SaMD, combination products, or IVD development is a plus.
• Language Requirement: English – Full proficiency reading/writing.
• If applicable, willing to relocate - flexible location residing in Austria or Spain.

What we offer

• One of the best overall career opportunities in the industry
• Accelerated professional development while working with global industry leaders.
• Very competitive salary/bonus
• 5 weeks vacation + local holidays
• Optimal work-life balance with a company policy and management approach built for sustainable career satisfaction
• Health insurance and a culture geared toward health and well-being
• An amazing collaborative team that is diverse, talented, and ready to celebrate success

About our company:

Suma Medtec accelerates development projects for medical device and pharmaceutical manufacturers of all sizes. We support all aspects of product development and commercialization, with specialized competencies in Global Regulatory Affairs, Risk Management, Human Factors, Project Management, R&D Engineering, and Quality. For additional information about Suma Medtec, we invite you to visit our website: www.suma-medtec.com

Suma Medtec GmbH is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage applications from candidates of all backgrounds, experiences, and perspectives.

Please note that applications received through third-party staffing or recruiting companies will not be considered.