About Elevaris Medical Devices

Tired of working at a "good" job?

At Elevaris, 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 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 leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

About the role

Elevaris is seeking an experienced, results-driven Senior Project Manager to lead medium-to-large, complex programs that support strategic business objectives across the organization. This role is primarily focused on New Product Introduction (NPI) and the accompanying activities, (e.g. manufacturing capacity expansion, cost reduction, and operational improvement initiatives) within a regulated medical device environment.

The Senior Project Manager will own end-to-end program execution, leading cross-functional and cross-site teams through the full project lifecycle using disciplined project management methodologies, including stage-gate governance. This individual is accountable for scope, cost, schedule, and operational outcomes, ensuring projects are delivered safely, on time, within budget, and in compliance with applicable quality and regulatory standards.

What you'll do

Working closely with Commercial, Engineering, Operations, Quality, Supply Chain, Customers, and external partners, this role translates development and operational requirements into scalable, production-ready manufacturing solutions that meet customer timelines and internal performance expectations. The Senior Project Manager drives proactive risk management, transparent communication, and timely escalation to senior leadership while maintaining a strong sense of urgency and ownership.

ESSENTIAL FUNCTIONS/MAJOR RESPONSIBILITIES: 

Program & Project Leadership

• Lead medium-to-large, complex NPI and manufacturing programs from concept through industrialization and steady-state production.
• Establish clear project scope, objectives, deliverables, timelines, and success criteria aligned with business priorities.
• Apply structured project management practices, including stage-gate reviews, to ensure disciplined execution and governance.

 Cross-Functional Team Leadership

• Build, lead, and coordinate cross-functional teams including Commercial, Engineering, Operations, Quality, Supply Chain, Finance, Customers, and external partners.
• Drive accountability across teams while fostering collaboration and alignment toward shared objectives.
• Ability to work globally with a diverse team.

 Schedule, Cost & Resource Management

• Develop and maintain detailed project schedules, budgets, and resource plans.
• Track milestones, identify critical path risks, and implement corrective actions to ensure on-time and on-budget delivery.
• Monitor expenditures, analyze cost variances, and drive cost-control actions.

 Risk, Quality & Compliance Management

• Identify, assess, and proactively mitigate technical, operational, quality, and regulatory risks throughout the project lifecycle.
• Ensure projects comply with applicable regulatory, quality, and safety requirements (e.g., ISO 13485, GMP).
• Partner with Quality to ensure design transfer, validation, and production readiness requirements are met.

Manufacturing Capacity & Operational Excellence

• Lead projects focused on increasing manufacturing capacity, improving throughput, reducing cost, and enhancing overall equipment and facility performance.
• Support the establishment or expansion of manufacturing operations, including greenfield and brownfield initiatives.

 Stakeholder Communication & Reporting

• Serve as the primary point of contact for project stakeholders, providing clear, consistent communication on progress, risks, and key decisions.
• Act as the primary customer facing team member.
• Prepare and deliver project updates, dashboards, and executive-level reviews.
• Escalate scope changes, cost impacts, and schedule risks promptly with recommended mitigation plans.

 Values & Leadership

• Uphold and role-model Elevaris’ core values of Integrity, Investment, Inclusion, and Ingenuity.
• Perform other duties as assigned to support business needs.

 MINIMUM REQUIREMENTS:

• Bachelor’s degree in engineering or related technical discipline.
• Minimum 7-10years of industry experience, including 3–5 years in a project or program management role.
• Strong knowledge of medical device New Product Introduction (NPI) and manufacturing processes, including metal forming or precision manufacturing.
• Proven experience managing scope, cost, schedule, and cross-functional teams on complex manufacturing projects.
• Strong 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.

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 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.