Description
Mackinnon Bruce is retained with a key client of ours who is looking to add a Senior Product Manager to their growing team. The client is a start-up, point-of-care diagnostics equipment manufacturer based in Massachusetts, USA it is in a stage of product development and needs a Senior Product Manager to oversee the end-to-end product development and commercialisation of their flagship technology.
The role is a hybrid position (2-3 days per week on-site) and requires someone with a deep understanding of the medical device or biotechnology product lifecycle and someone who has demonstrated the ability to develop and commercialise a product within the Life Science market. This position will be working cross-functionally with other key business units including but not limited to Commercial, Quality Assurance, Marketing, R&D, and Manufacturing.
Experience & Qualifications
- Bachelor’s degree in Biomedical Engineering or other related scientific discipline. Master’s degree is preferred.
- At least 10 years experience within the medical device industry or a related field, with a proven track record of successfully commercialising medical devices in U.S. and international markets.
- Strong program management skills with the ability to lead cross-functional teams.
- Excellent communication and leadership skills.
- Exceptional problem-solving skills and the ability to make data-driven decisions.
- Experience with regulatory approvals and compliance, particularly in the United States (FDA regulations) and international markets.
- Prior experience in a start-up environment is a plus.
If you are interested in hearing more please apply or reach out to me directly at elliot.green@mackinnon-bruce.com
Role & Responsibilities
Responsibilities
- Lead and work cross-functionally to ensure the development and refinement of vitro diagnostic devices, in line with the company’s goals
- Take responsibility for product definition, roadmaps, and specifications. Working closely with the R&D and Manufacturing teams
- Work closely with the sales and marketing teams to develop go-to-market strategies and product positioning.
- Develop and manage projects in collaboration with cross-functional teams, including risk mitigation, to achieve milestones and within budget.
- Work closely with the regulatory affairs team to confirm product classification and associated FDA and international requirements. Ensure that the product satisfies applicable FDA and international regulatory requirements and complies with applicable quality standards and regulations.
- Collaborate with engineering, manufacturing, and operations teams to optimize production processes, ensuring scalability, efficiency, and cost-effectiveness. Drive to improve yield, streamline processes, and decrease cycle times.
- Work with cross-functional teams in design, process, equipment support, testing, and failure analysis to fully understand device performance and potential failure modes. Report results to cross-functional teams for feedback and further requirements definition.
- Proactively identify, document, and mitigate risks throughout the product development lifecycle.
- Communicate with colleagues, and other stakeholders in a clear, concise manner through oral updates, meetings, and written reports, including providing status updates and recommendations to Senior Leadership.
