Product Owner/Manager- Medical

About the Role
We are seeking an experienced and driven Product Owner/Manager with a strong background in medical hardware product development . This role is critical in bridging the gap between clinical needs, engineering, regulatory requirements, and market demands to ensure delivery of high-impact, safe, and effective medical devices.
The ideal candidate will possess a deep understanding of the medical hardware lifecycle, from concept through commercialization, including regulatory pathways (e.g., FDA, CE), and will be adept at translating customer and stakeholder needs into well-defined product features and development roadmaps. Key Responsibilities

• Own the product roadmap , strategy, and backlog for one or more medical hardware devices.
• Collaborate closely with cross-functional teams (R&D, QA/RA, Clinical, Manufacturing, Marketing, and Sales) to guide product development from concept through launch.
• Translate clinical and customer insights into detailed product requirements , use cases, and user stories.
• Prioritize features and enhancements based on business value, regulatory impact, and user needs.
• Act as the voice of the customer and advocate for user-centered design and usability.
• Participate in design reviews , risk management, and verification/validation activities to ensure compliance with applicable standards (e.g., ISO 13485, IEC 60601).
• Support submission of regulatory documents and documentation for CE mark, FDA 510(k)/PMA, or other market approvals.
• Monitor and assess product performance in the field and lead post-market improvement initiatives.
• Collaborate with commercial teams to develop go-to-market strategies, pricing, and positioning.

Qualifications
Required:

• Bachelor's degree in Engineering, Biomedical Sciences, or a related field.
• 5+ years of experience in product management or product ownership roles within the medical device or healthcare technology industry.
• Hands-on experience managing hardware product development , ideally Class II or III medical devices.
• Familiarity with regulatory and quality requirements in medical device development (FDA, CE, ISO 13485, IEC 62304).
• Experience working in Agile or hybrid development environments.
• Excellent communication, organizational, and leadership skills.

Preferred:

• Advanced degree (MBA, MS, or equivalent) in business, engineering, or healthcare.
• Experience integrating hardware with software or digital health components.
• Clinical or healthcare workflow knowledge.
• PMP or Scrum Product Owner certification.

Our benefits package includes: (EXCLUDE on perm placements)

• Comprehensive medical benefits
• Competitive pay
• 401(k) retirement plan
• ...and much more!

About INSPYR Solutions
Technology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.

INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities