Engineering Manager, R&D

Position Title and Location

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

Message From The Hiring Manager

Caldera Medical is scaling its R&D organization to accelerate new product development, sustain existing product lines, and strengthen engineering execution across the portfolio. This Engineering Manager will lead a team of design, development, and sustaining engineers to deliver on the product roadmap while ensuring compliance with FDA and international regulatory requirements. The role is critical to maintaining Caldera's competitive advantage in pelvic floor therapies and supporting expansion into adjacent women's health categories.

Duties And Responsibilities

• Lead and manage a team of R&D engineers through all phases of product development from concept through commercialization
• Own the engineering project portfolio: set priorities, allocate resources, manage timelines, and ensure deliverables meet quality and regulatory standards
• Drive design control processes in accordance with FDA 21 CFR 820, ISO 13485, and EU MDR requirements
• Partner cross functionally with Quality, Regulatory, Operations, and Commercial teams to ensure seamless product launches
• Develop and mentor engineering talent; build a high performance team culture aligned with Caldera's mission and values
• Manage engineering budgets, capital expenditures, and vendor/contractor relationships
• Support sustaining engineering activities including CAPAs, design changes, and supplier qualifications
• Present project status risks and resource needs to executive leadership on a regular cadence
  
  

20% Travel expected

Required Knowledge, Skills And Abilities

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline (Master's preferred)
• 8 years of progressive engineering experience in the medical device industry, with at least 3 years in a people management role
• Direct experience with Class II or Class III medical devices through full product development lifecycle (concept to market)
• Working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and EU MDR
• Experience managing engineering budgets and vendor relationships
• Strong proficiency in CAD (SolidWorks preferred), PLM systems, and engineering documentation practices
  
  

Desired Knowledge, Skills, And Abilities

• Leadership & People Development: Proven ability to build, motivate, and develop engineering teams in a fast paced, resource constrained environment
• Technical Depth in Medical Devices: Strong working knowledge of design controls, risk management (ISO 14971), biocompatibility, and manufacturing process validation
• Project & Portfolio Management: Demonstrated skill managing multiple concurrent development programs with competing priorities
• Cross Functional Collaboration: Track record of effective partnership with Quality, Regulatory, Operations, and Commercial stakeholders
• Problem Solving & Decision Making: Ability to diagnose root causes, make sound technical decisions under uncertainty, and drive issues to closure
• Communication: Clear, concise communicator who can translate complex engineering topics for executive and non technical audiences
  
  

Competitive Compensation, Comprehensive Benefits, and more!

• $___ Annual Salary
• Medical and Dental Benefits – 75% 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
• 10 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.