R&D Systems Engineer

Caldera Medical, Inc.; Westlake Village (CA); On-site; USD 110,000 - 180,000; Full time

Benefits offered by this job

Relocation assistance

Medical and Dental Benefits

Vision Coverage

401(k) with 4% matching

Basic Life and AD&D

Unlimited Vacation Policy

6 Weeks Paid Maternity Leave

10 paid holidays

Collaborative culture

Job summary

Caldera Medical in Westlake Village, CA, is seeking a Systems Engineer to act as the technical thread across our R&D programs, uniting mechanical, electrical, and software work to deliver integrated medical devices.

In this individual contributor role, you will connect dots between disciplines, maintain solid design documentation, and influence multiple programs toward successful launches while ensuring FDA 510(k) readiness.

Qualifications

• BSEE, BSECE, or equivalent required.
• 5–7 years of medical device systems engineering experience.
• Experience aligning mechanical, electrical, and software engineers without direct authority.
• Experience authoring requirements, design inputs/outputs, and FDA 510(k) documentation.
• Knowledge of V&V planning and risk management.

Responsibilities

• Connect mechanical, electrical, and software work across programs with aligned, documented decisions.
• Author and maintain requirements, design inputs/outputs with traceability for FDA 510(k).
• Apply board- and component-level understanding to fit electrical and mechanical pieces.
• Collaborate with Electrical, Mechanical, and firmware/software teams to move programs to launch.
• Ensure verification and validation plans are thorough across disciplines.
• Support design FMEAs and risk management with Quality.
• Prioritize across a varied project portfolio to focus effort where it matters most.

Skills

Systems engineering

FDA 510(k) experience

Requirements tracing

Cross-functional collaboration

V&V planning

Risk management

Education

BSEE / BSECE or equivalent

Job description

R&D Systems Engineer

Research & Development

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 pelvic health and neuromodulation solutions. Our growing R&D team is developing the next generation of connected device technology while continuing to advance the surgical products clinicians rely on today.

Headquartered in Westlake Village, CA, with international operations in Neuchâtel, Switzerland, Caldera combines clinical insight with engineering excellence to bring meaningful therapies to market.

The Opportunity

Do you see the whole system — and love being the person who makes mechanical, electrical, and software work come together? We're looking for a Systems Engineer to be the technical thread across our R&D programs.

When a mechanical change affects a board, or a software decision changes a test plan, you'll be the one who connects the dots, aligns the team, and keeps the design documentation solid. It's an individual contributor role with real influence: you'll help multiple programs reach launch and shape how our products come to market.

What You'll Do

• Connect mechanical, electrical, and software work across multiple active programs, keeping design decisions aligned and documented.
• Author and maintain requirements, design inputs, and design outputs with traceability through FDA 510(k) submission.
• Apply board- and component-level understanding to how electrical and mechanical pieces fit together.
• Partner with Electrical, Mechanical, and firmware/software teams to move programs through design freeze and launch.
• Ensure the accuracy and thoroughness of verification and validation (V&V) plans across disciplines.
• Support design FMEAs and risk management with Quality.
• Prioritize across a varied project portfolio, focusing effort where it matters most.

Required Experience

• BSEE, BSECE, or equivalent.
• 5–7 years of systems engineering experience in medical devices; an electrical engineering background is a plus.
• A track record of aligning mechanical, electrical, and software engineers without direct authority.
• Experience authoring requirements, design inputs/outputs, and traceable documentation supporting FDA 510(k) submissions.
• Working knowledge of V&V planning and execution, design FMEA, and risk management.
• Comfort managing several programs at different stages at once.

Don't meet every requirement? If you bring strong medical device systems experience and most of the above, we encourage you to apply.

Why This Role Matters

As our pipeline grows, R&D needs one person keeping every discipline working from the same requirements. You'll have a hand in every program you touch — and see the products you helped shape reach the women who need them.

Competitive Compensation, Comprehensive Benefits, and more!

• Relocation assistance available for this role
• Medical and Dental Benefits
• 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 - including your birthday!
• 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 veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.