About Elevaris Medical Devices

Tired of working at a "good" job?

At Elevaris Medical Devices, our goal is not to be good, it's to be extraordinary.

Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values of Integrity, Investment, Inclusion and Ingenuity describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.

Elevaris Medical Devices is a Contract Development and Manufacturing Organization (CDMO) for industry-leading, multi-national healthcare companies, global Original Equipment Manufacturers (OEMs), and emerging technology companies. It is one of the world's leading manufacturers of made-to-spec procedural needles and specializes in the manufacture of precision micro-components, complex tubular components, and sub-assemblies for the medical device industry. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

About the role

A unique opportunity supporting our Korea location. Requires ability to work flexible hours due to the global nature of the role and must be fluent in Korean.

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.

What you'll do

Program & Project Leadership

• 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.

 Schedule, Cost & Resource Management

• 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.

 Risk, Quality & Compliance Management

• 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.

 Manufacturing Capacity & Operational Excellence

• Contribute to projects focused on improving manufacturing capacity, efficiency and cost.

• Support the establishment or expansion of manufacturing operations, including greenfield and brownfield initiatives.

 Stakeholder Communication & Reporting

• 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.

 Values & Leadership

• 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.

MINIMUM 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

PREFERRED SKILLSET:

• 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

PHYSICAL DEMANDS & ADA STATEMENT:

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. The employee is also required to interact with a computer and communicate with peers, co-workers and external partners. Contact your manager or HR to understand the Work Conditions and Physical requirements that may be specific to your role.

An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.