Project 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 lifecycles, 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.

Responsibilities

• 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.

Essential Skills

• 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 terms of 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).

Additional Skills & Qualifications

• Master’s degree in Engineering, Business Administration, or a related field is preferred.
• Experience in sustainable design and engineering management within a medical device or similarly regulated environment.
• Work history in customer relations, including managing expectations and maintaining long-term partnerships.
• Experience supporting or leading 510(k) submissions or similar regulatory pathways is a plus.
• Demonstrated ability to mentor and coach junior project managers and team members.
• Comfort working in a contract development and manufacturing environment with multiple concurrent projects.
• PMP certification is highly preferred and will be considered a strong differentiator.

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