Job Description

Position: Project Manager - Medical Device Development

Level: Mid-Level to Senior

Type : Internal, Full-time

Location : This position is available for the Midwest region in the USA or Tyrol, Austria (Austrian work permit provided for non-EU candidates)

Job description : This is a full-time role for a Project Manager – Medical Device Development with flexible location based in the USA or Austria. 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 Project Manager will own design initiatives across all life cycle stages.

Responsibilities:

• Drive development projects across all design stages, collaborating with subject matter experts to complete deliverables.
• Draft or review key Design History File documents (DIR, Design Verification report, etc.) and deliver phase reviews.
• Ensure adherence to Design Controls and applicable Regulatory framework. Collaborate with manufacturers as technical lead, planning assemblies required for testing, clinical trial, or commercial production.
• Ensure that medical device Risk Management and Usability considerations are documented according to applicable processes and guidance (e.g., ISO 14971, IEC 62366).
• Draft, review, and maintain risk documentation related to design and user interactions (RM Plan, FMEA, URRA, Task/Comparative Analysis, etc.).
• Support user validation and Post-Market Surveillance activities.
• Identify requirements for medical devices to support regulatory submissions.
• Support Regulatory Affairs in preparing medical device and/or combination product pre-registration documents (various regions).
• Provide input to health authority questions. Communicate project updates to stakeholders.
• Work with common word processing tools and spreadsheets (e.g., Microsoft Office), and share/present online in video conferences.

Candidate profile and required qualifications: 

• Relevant Experience: a minimum of 5 years (8+ years for Senior) within the medical device or pharmaceutical industry is required (e.g., developing medical devices, combination products, IVDs, SaMD).
• Studies: BS, MS, or PhD. in Engineering or health-related field.
• Self-directed, works independently in a remote setting or 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 submission preparation is a plus.
• Language Requirement: English – Full proficiency reading/writing.
• If applicable, willing to relocate to Austria.
• Interested in gaining experience in multiple key roles of medical device development, across various technologies.

What we offer:

• Very competitive salary/bonus
• 5 weeks of vacation + local holidays
• Health insurance and a culture geared toward health and well-being
• Enhanced learning and career development opportunities

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, Project Management, R&D Engineering, Quality, and Risk Management. For additional information about Suma Medtec, we invite you to visit our website:

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 only candidates who submit their applications directly to us will be considered for this opportunity; applications received through third-party staffing or recruiting companies will not be reviewed.

Job Tags

Similar Jobs