Senior Project Manager Engineer; Medical Device Manufacturing - REMOTE

Senior Project Manager (New Product Introduction & Manufacturing)

Department: Project Management & Engineering
Reports To: Senior Director, Engineering & Project Execution
Employment Type: Full-Time | Exempt

We are seeking an experienced, results‑driven Senior Project Manager to lead medium‑to‑large, complex programs supporting strategic business objectives within a regulated manufacturing environment. This role is heavily focused on New Product Introduction (NPI) along with manufacturing capacity expansion, cost reduction, and operational improvement initiatives. The position owns end‑to‑end program execution, leading cross‑functional and cross‑site teams through the full project lifecycle using disciplined project management methodologies, including stage‑gate governance.

The Senior Project Manager is accountable for scope, cost, schedule, risk, and operational outcomes, ensuring projects are delivered safely, on time, within budget, and in compliance with applicable quality and regulatory requirements. Working closely with Engineering, Operations, Quality, Supply Chain, Commercial teams, customers, and external partners, this role translates development and operational requirements into scalable, production‑ready manufacturing solutions.

• Lead complex NPI and manufacturing programs from concept through industrialization and steady‑state production.
• Define project scope, objectives, timelines, deliverables, and success metrics aligned with business priorities.
• Apply structured project management methodologies, including stage‑gate reviews, to ensure disciplined execution and governance.

• Build and lead cross‑functional teams across Engineering, Operations, Quality, Supply Chain, Finance, Commercial, customers, and external partners.
• Drive accountability while fostering collaboration and alignment toward shared objectives.
• Effectively lead and coordinate global and cross‑site teams.

• Develop and maintain detailed project schedules, budgets, and resource plans.
• Track milestones, manage critical paths, and implement corrective actions to maintain delivery commitments.
• Monitor project spend, analyze variances, and drive cost‑control initiatives.

• Identify, assess, and mitigate technical, operational, quality, and regulatory risks throughout the project lifecycle.
• Ensure compliance with applicable regulatory, quality, and safety standards (e.g.,
  ISO 13485, GMP
  ).
• Partner with Quality and Engineering to support design transfer, validation, and production readiness.

• Lead initiatives focused on increasing manufacturing capacity, improving throughput, reducing cost, and enhancing equipment and facility performance.
• Support the establishment, expansion, or optimization of manufacturing operations.

• Serve as the primary point of contact for internal and external stakeholders.
• Act as the primary customer‑facing project representative.
• Deliver clear project updates, dashboards, and executive‑level reviews.
• Proactively escalates risks, scope changes, and schedule or cost impacts with recommended mitigation plans.

(Candidates must meet these requirements to be considered)

• Bachelor’s degree in Engineering or a related technical discipline.
• 7–10 years of industry experience, including 3–5 years in project or program management.
• Strong experience with medical device NPI and regulated manufacturing environments.
• Demonstrated success managing scope, schedule, cost, and cross‑functional teams on complex manufacturing programs.
• Ability to read and interpret engineering drawings, specifications, and manufacturing documentation.
• Strong leadership, communication, and stakeholder management skills.
• Proficiency with project management tools and systems.
• Ability to travel internationally as required.

(Will receive additional consideration)

• Master’s degree in engineering, Operations, or Business.
• Experience in private equity–backed or high‑growth organizations.
• Background in…