Project Manager

Elevaris Medical Devices•Wilmington, MA

19d

About The Position

The Project Manager will lead small-to-medium New Product Introduction (NPI) and manufacturing-related projects that support strategic business objectives. This role is focused on executing projects such as product launches, capacity expansion, cost reduction, and operational improvement initiatives within a regulated medical device environment. The Project Manager is responsible for driving day-to-day project execution across the full lifecycle, applying established project management methodologies, including stage-gate processes. Working under the guidance of senior leadership, this role manages scope, schedule, cost, and cross-functional coordination to ensure projects are delivered on time, within budget, and in compliance with quality and regulatory standards. This individual collaborates closely with Commercial, Engineering, Operations, Quality, and Supply Chain teams to translate project requirements into executable plans. The Project Manager proactively identifies risks, supports issue resolution, and escalates complex challenges as needed, while maintaining clear communication with stakeholders.

Requirements

Bachelor’s degree in engineering or related technical discipline.
2-5 years of industry experience, including 1-3 years hands-on project coordination or project management.
Foundational understanding of New Product Introduction (NPI) and manufacturing processes, including metal forming or precision manufacturing.
Experience supporting cross-functional teams on technical or operational projects.
Strong organizational, communication, leadership, and stakeholder-management skills.
Ability to read and interpret engineering drawings, specifications, and manufacturing documentation.
Proficiency with project management tools and systems.
Ability to travel internationally, as needed.

Nice To Haves

Master’s degree in engineering, operations, or business.
Experience in private-equity-backed organizations, particularly during periods of transformation or rapid growth.
Background in medical devices, life sciences, or regulated manufacturing, including:
Single-use assemblies
Bioprocessing components
Medical textiles
Advanced engineered materials
ISO 13485 experience is strongly preferred.
Certification in PMP, Lean, Six Sigma, or related disciplines.
Experience establishing or scaling manufacturing operations, including greenfield and brownfield facilities.
Exposure to digital manufacturing, automation, MES, or advanced analytic

Responsibilities

Lead execution of small-to-medium, NPI and manufacturing programs from concept through industrialization and steady-state production.
Support definition of project scope, objectives, deliverables, timelines, and success criteria aligned with business priorities.
Apply standard project management practices, including stage-gate reviews, to ensure consistent execution.
Coordinate cross-functional teams including Commercial, Engineering, Operations, Quality, Supply Chain, Finance, Customers, and external partners.
Facilitate team alignment, track action items and ensure timely follow-through on deliverables
Support collaboration across global teams and functions.
Develop and maintain detailed project schedules, budgets, and resource plans with guidance as needed.
Track progress against milestones and identify potential delays or risks to the critical path.
Monitor project costs and support variance tracking/reporting.
Identify, assess, and proactively mitigate technical, operational, quality, and regulatory risks throughout the project lifecycle.
Ensure adherence to applicable quality and regulatory requirements (e.g., ISO 13485, GMP).
Partner with Quality and Engineering to support design transfer and production readiness activities.
Contribute to projects focused on improving manufacturing capacity, efficiency and cost.
Support the establishment or expansion of manufacturing operations, including greenfield and brownfield initiatives.
Provide regular project updates to stakeholders, including status, risks, and key milestones.
Support preparation of project dashboards and reports for leadership review.
Escalate issues, risks, and scope changes to senior project leadership with recommended actions.
Uphold and role-model Elevaris’ core values of Integrity, Investment, Inclusion, and Ingenuity.
Contribute to a collaborative, accountable and results-oriented team environment.
Perform other duties as assigned to support business needs.