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Senior Program Manager

Engineering | Agoura Hills, CA | Full Time

Job Description

 

Senior Program Manager

Caldera Medical’s Mission - To Improve the Quality of Life for Women!

The Position

  • This position will be a key member of R&D organization and will manage multiple projects

  • Lead projects for class II and III medical devices ranging from medium to large complexity

  • Create project plan, schedule, budget and resource plan

  • Ensure adherence to design controls, regulatory requirements and quality management system

  • Own project schedule, and track project activities with critical path analysis

  • Synchronize and follow through on project tasks among cross-functional groups

  • Manage conflicts within team and manage project priorities

  • Forecast project risks and highlight to upper management with proposed resolution plan

  • Support all activities from project initiation to commercial launch

  • Ensure robust product development and a seamless transition to manufacturing

  • Interface with R&D, marketing and regulatory to ensure all requirements are captured

  • Continuously challenge teams to improve on performance, schedule and budget

  • Further develop program management function per ISO 13485 and 21 CFR 82

The Company:

  • Rapidly growing medical device manufacturer helping women suffering from stress incontinence and pelvic organ prolapse

  • Developing exciting new products to treat other conditions women unnecessarily suffer from

  • Located in beautiful Agoura Hills, CA in North Los Angeles County

The Culture:

  • A Culture of family and team…not a corporate goliath where you’re just another number

  • All employees get a seat at the table and have influence with management

  • Women’s Health Initiative - Giving back to those who can’t afford treatment 

    • Goal to treat 1 million women suffering from incontinence by 2025!

The Requirements:

  • Bachelor of Engineering in Mechanical, Electrical or Software Engineering

  • Must have a minimum of 3-5 years of experience as a project manager in biotech industry

  • Project Management Professional Certification (PMP) or equivalent

  • Fundamental knowledge of engineering principles for meaningful participation in design reviews

  • Experience in taking class II or class III medical device products to commercialization

  • Ability to multi-task, prioritize and collaborate

  • Demonstrated ability to find win-win situations and resolve conflicts

  • Deep understanding of regulatory submission process, quality systems and risk management

  • Positive thinking, energetic with excellent communication and team-building skills

The Benefits:

  • Medical / Dental Benefits – 75% paid for employee and family members
  • 401(k) with 4% matching contributions

  • Basic Life and AD&D

  • Unlimited Vacation

  • 6 Weeks Paid Maternity Leave

  • Kitchen stocked with free snacks and drinks

  • Being surrounded by talented and engaged employees

Learn more about us on Glassdoor - https://www.glassdoor.com/Reviews/Caldera-Medical-Reviews-E356568.htm