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NOW Hiring Heroes, Inc. · 1 day ago

Senior Project Manager Engineer (Medical Device Manufacturing) - REMOTE

United States

Full-time

Remote

Senior Level

7+ years exp

NOW Hiring Heroes is seeking an experienced Senior Project Manager to lead complex programs in the medical device manufacturing sector. This role focuses on New Product Introduction and operational improvement initiatives while ensuring compliance with quality and regulatory standards.

Human ResourcesProfessional ServicesRecruitingStaffing Agency

Responsibilities

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 escalate risks, scope changes, and schedule or cost impacts with recommended mitigation plans

Qualification

Medical Device NPIRegulated ManufacturingProject ManagementISO 13485PMP CertificationStakeholder ManagementRisk ManagementLeadershipCommunicationCross-Functional Team Leadership

Required

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

Preferred

Master's degree in engineering, Operations, or Business

Experience in private equity–backed or high-growth organizations

Background in regulated manufacturing sectors such as: Medical devices or life sciences, Single-use assemblies, Bioprocessing components, Medical textiles, Advanced engineered materials

Hands-on experience with ISO 13485 environments

Certifications such as PMP, Lean, Six Sigma, or similar

Experience scaling manufacturing operations or launching new facilities

Exposure to automation, digital manufacturing, MES, or advanced analytics