R&D Program Manager

Located in Westlake Village, CA; Onsite - No remote option.

Message from the Hiring Manager:

Caldera Medical's R&D pipeline continues to expand with active and upcoming projects spanning implantable devices, surgical instruments, and technology-enabled therapeutics. As the portfolio grows, the need for a dedicated Program Manager to drive cross-functional coordination, maintain project discipline, and ensure timely execution has become critical.This role will serve as the central hub connecting R&D Engineering, Regulatory, Quality, Operations, Marketing, and Commercial teams to ensure engineering projects advance from concept through commercialization on time, on budget, and in compliance with all regulatory requirements. The Program Manager will bring structure, visibility, and accountability to the R&D project portfolio, enabling leadership to make informed resource and prioritization decisions while removing cross-functional barriers that slow project velocity.
Duties and Responsibilities:

Cross-Functional Program Leadership

• Own and manage the integrated project schedule for all active R&D engineering projects, ensuring alignment across Engineering, Regulatory, Quality, Operations, and Commercial functions.

• Facilitate design reviews, stage-gate meetings, and cross-functional team meetings to drive decisions and remove roadblocks.• Serve as the single point of accountability for project timelines, deliverables, and resource coordination across departments.

Project Planning & Execution

• Develop and maintain detailed project plans including timelines, milestones, budgets, resource requirements, and risk registers.

• Track project performance against plan and proactively escalate risks, dependencies, and resource conflicts to leadership.

• Ensure all project activities comply with FDA 21 CFR 820, ISO 13485, and Caldera's design control procedures.Portfolio Visibility & Reporting

• Create and maintain an R&D portfolio dashboard providing real-time visibility into project status, resource utilization, and key milestones.

• Prepare and deliver executive-level project status reports for Monthly Business Reviews and leadership meetings.

• Track and report on project budgets and spending against approved plans.Process Improvement & Scalability

• Establish and continuously improve standardized project management frameworks, templates, and tools for R&D.

• Implement best practices for cross-functional communication, meeting cadence, and decision documentation.

• Drive post-project retrospectives to capture lessons learned and improve future execution.Stakeholder & Vendor Management

• Coordinate with external vendors, contract manufacturers, and testing laboratories to ensure on-time delivery of project dependencies.

• Act as a liaison between R&D leadership and other department heads to align project priorities with company strategic goals
Required Knowledge, Skills and Abilities:

• Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field.
• 3+ years of program/project management experience in healthcare or medical device industry
• Direct experience managing Class II and/or Class III device development programs through design controls and regulatory submissions (510(k), PMA)
• Demonstrated success leading cross-functional teams in a matrixed organization without direct authority.
• PMP certification preferred; familiarity with Agile/hybrid methodologies a plus.
• Experience with project portfolio management tools and executive-level reporting.
• Strong understanding of manufacturing transfer, supplier management, and commercialization processes for medical devices.

Competitive Compensation, Comprehensive Benefits, and more!

• $110,000-140,000 Annual Salary
• Medical and Dental Benefits – paid for employee and family members
• Vision Coverage
• 401(k) with 4% matching contributions after 90 days of employment
• Basic Life and AD&D
• Unlimited Vacation Policy
• 6 Weeks Paid Maternity Leave
• 7 paid holidays
• Being surrounded by amazing people!

(This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position.)

Our Culture- Where Career and Passion come together!

• 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. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
• The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

Who is Caldera Medical?

Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.