Elevaris Medical Devices is a leading Contract Development and Manufacturing Organization specializing in medical devices. The Project Manager will lead New Product Introduction and manufacturing-related projects, ensuring timely execution and compliance with quality standards while collaborating with cross-functional teams.
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
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, 25%
- Fluent in Korean
- 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