Project Manager Level III
Listed on 2026-05-24
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Engineering
Manufacturing Engineer, Quality Engineering
Role Overview
Elevaris Medical Devices is a Contract Development and Manufacturing Organization (CDMO) that designs and manufactures precision micro‑components, procedural needles, and complementary pharmaceutical products for the medical device industry.
Responsibilities- Lead execution of small‑to‑medium New Product Introduction (NPI) and manufacturing programs from concept through industrialization and steady‑state production.
- Define 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.
- Track progress against milestones, identify potential delays or risks to the critical path, and monitor project costs.
- 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.
- Bachelor’s degree in engineering or a related technical discipline.
- 2–5 years of industry experience, including 1–3 years of 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, up to 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, and 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 analytics.
The physical demands described within the Essential Functions section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile, interact with a computer, and communicate with peers, co‑workers, and external partners.
EqualEmployment Opportunity
Elevaris is an Equal Opportunity…
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