Project Manager, Program ​/ Project Manager, Operations Manager

Job Description

This Sr. Project Manager role leads complex project initiatives within the medical device sector, with a primary focus on new product development from concept through commercialization. You will coordinate cross‑functional teams, manage full product life cycles, and ensure that project timelines, budgets, and resources align with customer requirements and regulatory standards. The position requires a strategic, hands‑on leader who can drive project execution, maintain strong quality and compliance practices, and support business growth in a dynamic, highly regulated environment.

• Lead and coordinate cross‑functional teams to drive medical device product development projects from early concept through commercialization.
• Develop comprehensive project plans that include detailed timelines, budgets, resource allocation, and risk management strategies.
• Oversee and manage the entire product lifecycle, ensuring smooth transitions between development phases and alignment with business objectives.
• Act as the primary point of contact for internal and external stakeholders, providing clear and regular project updates while managing expectations.
• Ensure all projects comply with applicable regulatory requirements and internal quality system processes.
• Facilitate effective communication and collaboration among engineering, quality, regulatory and other functional teams to enhance project performance.
• Identify, assess, and mitigate project risks to minimize impacts on timelines, budgets and deliverables.
• Conduct formal project reviews, capture lessons learned and implement improvements to drive continuous enhancement of project management practices.
• Support business development efforts by assessing project feasibility and evaluating potential impacts on timelines, profitability and resource needs.
• Collaborate with product development engineering teams, including catheter and other device‑focused projects, to ensure technical requirements and customer specifications are met.
• Develop and maintain risk management plans and project documentation in alignment with quality and regulatory expectations.
• Cultivate strong customer relationships by understanding their needs, providing transparent updates and ensuring delivery of high‑quality products.
• Mentor and guide junior project managers in project management best practices, tools and processes.
• Contribute to sustainable design initiatives and engineering management activities to support long‑term product and portfolio success.
• Support and help drive 510(k) projects by organizing remaining work, resolving issues and ensuring successful completion and submission.

• Bachelor’s degree in Engineering, Business Administration or a related field.
• A minimum of 7 years of experience in project management, particularly within the medical device or highly regulated environment.
• Demonstrated experience leading and managing the entire product lifecycle from concept through commercialization.
• Proven track record managing complex projects with successful outcomes in scope, schedule, cost and quality.
• Strong work history in product development processes, including engineering and new product development in medical devices such as catheter‑related projects.
• Experience developing and executing detailed project plans, including timelines, budgets and resource allocation.
• Proficiency in risk management planning, including identification, assessment and mitigation of project risks.
• Experience working within and supporting robust quality systems management in a regulated industry.
• Strong leadership skills with the ability to influence and coordinate cross‑functional teams without direct authority.
• Exceptional communication and interpersonal skills, with the ability to engage stakeholders at all levels.
• Ability to manage multiple projects simultaneously while maintaining high attention to detail and organization.
• Familiarity with FDA regulations and exposure to the 510(k) process.
• Strong analytical and problem‑solving skills with a results‑oriented mindset.
• PMP certification or equivalent project management credential (highly preferred).