Program Manager, R&D - Selution

Location
Irvine
Workplace
On-site

About this role

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.


Responsibilities

The R&D Program Manager leads cross-functional project teams to ensure efficient planning, execution, and delivery of product development initiatives within the SELUTION™ platform. The role emphasizes program leadership, risk management, and adherence to regulatory and quality frameworks

 

 

 Key Responsibilities

  • Lead and coordinate multi-disciplinary R&D programs from concept to launch.
  • Maintain program schedules, risk registers, and milestone tracking.
  • Provide regular updates and dashboards to leadership.
  • Manage project budgets and ensure alignment with financial targets.
  • Ensure compliance with design controls (21 CFR 820) and documentation standards.
  • Facilitate collaboration among R&D, Clinical, and Regulatory teams.

Qualifications

Required Qualifications

  • 8+ years of experience in medical devices.
  • Previous program or project management experience.
  • Bachelor’s degree in Engineering or related field.
  • Mastery of FDA design controls and documentation requirements.

 

Preferred Qualifications

  • PMP certification or advanced project management training.
  • Experience with cardiovascular or combination product development.
  • Previous medical device program or project management experience.

 

 

Pay / Compensation
The expected pre-tax pay rate for this position is $111,650 – $159,500 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.


US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

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