Career Development Lead

Position : Medical Device Development Lead

Level : Mid - Senior

Type : Internal, Full-time

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

This is a full-time role for a Medical Device Development Lead with flexible location based in 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.

Drive device development projects across all design stages, collaborating with subject matter experts to complete deliverables following applicable Design Controls.

Draft 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., Collaborate with manufacturers as technical lead, planning assemblies required for testing, clinical trial, or commercial production.

Support Regulatory Affairs in preparing medical device pre-registration documents (various regions). Microsoft Office), and present online in video conferences.

Relevant Experience : a minimum of 5 years within the medical device or pharmaceutical industry is required (e.G., developing medical devices, SaMD, combination products, IVDs).

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. 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.). Interested in gaining experience in multiple key roles of medical device development, across various technologies.

Experience in medical device software development or connected SW / HW is a plus.

English – Full proficiency reading / writing.

Rapid learning and development opportunities on a global scale

~ 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

~ 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.