Product Manager

Caldera Medical; Park City (UT); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical and Dental

Vision Coverage

401(k) matching

Paid Maternity Leave

Unlimited Vacation

Job summary

Caldera Medical is seeking a Product Manager to own the Gynesis platform end-to-end—from clinical need to roadmap execution, through FDA 510(k) submission and V2 development. This on-site role in Park City, UT translates therapy claims, reimbursement considerations, and market needs into clear requirements.

You will maintain the backlog, balance trade-offs with engineering and regulatory, and be the voice of the customer—patients, physicians, and payers—to guide product decisions and releases.

Qualifications

• 5+ years of product management in medical devices or regulated consumer-health/wearables.
• 510(k) experience desirable.
• Strong cross-functional leadership with engineering, regulatory, and commercial teams.

Responsibilities

• Own the Gynesis product definition and roadmap end-to-end, from the current device through the next-generation platform.
• Translate clinical inputs, therapy claims, reimbursement strategy, and market needs into a prioritized product-requirements document (PRD) for the engineering team.
• Own product trade-off decisions in partnership with engineering and regulatory.
• Serve as the voice of the customer — patient, physician, and payer — translating needs into product requirements.
• Maintain the product backlog and priorities, and align engineering, regulatory, and commercial teams to a single product definition.
• Partner with regulatory affairs to keep requirements aligned to the FDA 510(k) predicate and cleared claims.
• Support pricing and value-proposition decisions with market and competitive analysis.
• Provide product-positioning inputs to the go-to-market team and define future development scope, including international markets and new indications.

Skills

Product management

Regulatory awareness

Cross-functional leadership

Medical devices experience

Education

BS in a technical field

Job description

Product Manager

** on site in Park City, UT**

Gynesis Platform - Neuromodulation Business Unit

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

About Caldera Medical

Caldera Medical is committed to improving the quality of life for women worldwide through innovative, minimally invasive pelvic health and neuromodulation solutions. Our Neuromodulation Business Unit is advancing the Gynesis platform, bringing a new generation of connected device technology to the clinicians and patients who rely on us.

The Opportunity

As our Neuromodulation Business Unit shifts to a product-development-first sequence, we're looking for a Product Manager to be the single owner of what we're building and why. You'll own the Gynesis product definition end-to-end - translating clinical need, therapy claims, reimbursement strategy, and market requirements into a prioritized roadmap and requirements the engineering team builds against, through design freeze, our FDA 510(k) submission, and into the V2 (BLE/app/provider portal) roadmap.

Today, product requirements are managed informally across engineering, clinical, and consulting resources. As the team scales, we need a dedicated owner of requirements, trade-offs, and the roadmap, so engineering, regulatory, and go-to-market stay aligned to one product truth. This role owns the what and why of the product and owns the when and how of schedule and execution.

What You'll Do

• Own the Gynesis product definition and roadmap end-to-end, from the current device through the next-generation platform.
• Translate clinical inputs, therapy claims, reimbursement strategy, and market needs into a prioritized product-requirements document (PRD) the engineering team builds against.
• Own product trade-off decisions in partnership with engineering and regulatory.
• Serve as the voice of the customer — patient, physician, and payer - translating their needs into product requirements.
• Maintain the product backlog and priorities, and keep engineering, regulatory, and commercial aligned to a single product definition.
• Partner with regulatory affairs to keep requirements aligned to the FDA 510(k) predicate and cleared claims.
• Support pricing and value-proposition decisions with market and competitive analysis.
• Provide product-positioning inputs to the go-to-market team and define future development scope, including international markets and new indications.

Required Experience

• 5+ years of product management experience in medical devices or regulated consumer-health/wearables.
• Experience owning requirements/roadmap through a regulatory submission (510(k) experience desirable).
• Comfort translating clinical claims and reimbursement considerations into product decisions.
• Strong cross-functional leadership with engineering, regulatory, and commercial teams.
• Women's health, femtech, or wearables experience is a plus.
• BS in a technical field or equivalent experience.

Why This Role Matters

As Gynesis scales past its current design phase, the program needs a single, dedicated owner of product requirements and roadmap — someone who keeps engineering, regulatory, and go-to-market working from one product definition instead of scope drifting across teams. You'll shape not just what ships through this submission, but the direction of the platform's next generation.

Competitive Compensation, Comprehensive Benefits, and more!

• Medical and Dental Benefits 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 dedicated to improving the quality of life for women through innovative surgical solutions for stress urinary incontinence, pelvic organ prolapse, polyps, and fibroids.

Our products are trusted by surgeons worldwide, and our commitment extends beyond medical advancements. We foster strong partnerships with surgeons and lead the largest humanitarian program in women's health, aiming to provide treatment to one million underserved women by 2027.

Guided by integrity, we prioritize patients, customers, employees, and the community over profit. As the fastest-growing women's health company, we remain committed to expanding education and access to life-changing care for women everywhere.

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 veterans' status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.