Job Description
Are you passionate about transforming patient outcomes through cutting-edge medical technology? Apex Medical Innovations is seeking a visionary Senior Medical Device Product Manager to lead the next generation of life-saving devices from concept to market launch.
As a key member of our Product Strategy team, you will bridge the gap between clinical needs, engineering feasibility, and business goals. We offer a collaborative culture where your expertise in regulatory compliance and market trends will directly shape our product roadmap.
Why Join Us?
- Competitive base salary and performance bonuses.
- Comprehensive health, dental, and vision insurance.
- Flexible PTO and professional development opportunities.
- State-of-the-art facilities in the heart of Boston’s biotech district.
Responsibilities
- Own the product lifecycle for assigned medical devices, including strategy definition, roadmap creation, and go-to-market execution.
- Collaborate closely with R&D, Regulatory Affairs, and Clinical Operations to ensure products meet rigorous safety and efficacy standards (FDA/CE).
- Drive cross-functional team alignment to deliver high-quality products on time and within budget.
- Conduct in-depth market research and competitive analysis to identify growth opportunities and unmet clinical needs.
- Manage stakeholder expectations, from executive leadership to end-users, ensuring clear communication of product vision and value proposition.
- Oversee product performance metrics and iterate on features based on user feedback and post-market surveillance data.
Qualifications
- Bachelor’s degree in Biomedical Engineering, Life Sciences, or related field; Master’s degree preferred.
- 5+ years of product management experience specifically within the medical device or healthcare technology sector.
- Deep understanding of FDA regulations (21 CFR Part 820), IEC 62304, and quality management systems.
- Proven track record of successfully launching medical products in a regulated environment.
- Strong analytical skills with the ability to interpret complex clinical data and technical specifications.
- Exceptional leadership and communication skills, capable of influencing cross-functional teams without direct authority.