Product Manager - Neuromodulation Platform

About Caldera Medical and the Opportunity

Caldera Medical is devoted to enhancing the quality of life for women globally by providing innovative, minimally invasive solutions in pelvic health and neuromodulation. Within their Neuromodulation Business Unit, the focus is on developing the Gynesis platform, a next-generation connected device technology designed to serve clinicians and patients effectively.

Located onsite in Park City, UT, this role is critical as the business unit shifts towards a product-development-first approach. The Product Manager will be the authoritative owner responsible for defining and managing the entire Gynesis product—from concept through to the next generation. This includes overseeing clinical needs, therapy claims, reimbursement strategies, and market requirements to shape a prioritized development roadmap. You will guide the team through design completion, FDA 510(k) submissions, and the evolution into version 2 enhancements (BLE/app/provider portal).

Key Responsibilities

• Complete ownership of the Gynesis product definition and roadmap, encompassing current device iterations and upcoming platform versions.
• Translate clinical feedback, therapeutic claims, market demands, and reimbursement frameworks into a comprehensive prioritized Product Requirements Document (PRD) for engineering implementation.
• Make and manage trade-offs in product features by collaborating closely with engineering and regulatory teams.
• Act as the voice for customers including patients, physicians, and payers to ensure their needs are embedded in product development.
• Maintain and prioritize the product backlog, aligning engineering, regulatory, and commercial teams toward a unified product vision.
• Partner with regulatory affairs to ensure consistency with FDA 510(k) predicate devices and approved claims.
• Support pricing and value proposition decisions through detailed market and competitor analysis.
• Contribute insights to go-to-market teams concerning product positioning and define scope for future development, including international expansion and new indications.

Required Experience and Qualifications

• Over 5 years of product management experience within medical devices or regulated consumer health/wearable technology sectors.
• Demonstrated history of managing product requirements and roadmaps through regulatory submissions, preferably with 510(k) experiences.
• Ability to interpret clinical claims and reimbursement considerations to influence product direction effectively.
• Strong leadership skills to coordinate across cross-functional teams such as engineering, regulatory, and commercial groups.
• Experience in women’s health, femtech, or wearables is highly advantageous.
• Bachelor’s degree in a technical discipline or equivalent practical experience.

Why This Role is Important

As Gynesis advances beyond design phases, a dedicated product lead is essential to unify product requirements and roadmap management. This role prevents scope drift, ensuring that engineering, regulatory, and commercial teams work cohesively from a single product definition. You will shape both the immediate product deliverables and the strategic roadmap for the platform’s future versions.

Compensation and Benefits

• Competitive salary package.
• Medical and dental insurance coverage extending to employees and their families.
• Vision insurance benefits.
• 401(k) plan with 4% matching contributions after 90 days of employment.
• Basic life and accidental death & dismemberment (AD&D) insurance.
• Unlimited vacation policy for work-life balance.
• Six weeks of paid maternity leave.
• Ten paid holidays annually.
• A supportive workplace filled with dedicated, passionate colleagues.

Organizational Culture and Values

• Emphasis on familial and team-based culture rather than corporate anonymity.
• Inclusive management style offering all employees influence in decisions.
• Strong community involvement, including charitable contributions and volunteer efforts focused on Southern California.
• Core commitment to the Women’s Health Initiative, prioritizing underserved women every day.
• Ambitious goal to treat one million women suffering from incontinence by 2027.

Company Mission

Caldera Medical strives to improve women’s health through surgical solutions tackling conditions such as stress urinary incontinence, pelvic organ prolapse, polyps, and fibroids. Recognized globally by surgeons, Caldera also leads the largest humanitarian efforts in women’s health, aiming to extend life-changing care and education to underserved populations worldwide. Integrity guides their approach, placing patients, employees, and communities above profits and fueling ongoing growth as a leader in women’s health innovation.

Equal Opportunity Statement

Caldera Medical is an equal opportunity employer that rigorously considers all applications without regard to race, color, religion, gender, nationality, age, disability, marital status, military or veteran affiliation, sexual orientation, gender identity, or other legally protected categories.