Senior Project Engineer

Senior Project Engineer 100% ONSITE - Westlake Village, CA (Visa sponsorship is not available for this opportunity) Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager : Includes the following. Other duties may be assigned. The Senior Project Engineer will be a key leader in the research and development of medical devices, overseeing projects from initial concept through to market launch and post-market surveillance. The role requires a deep understanding of medical device development, with specific expertise in implantable Class II and III devices and the stringent regulatory pathways required for their approval. This person will be responsible for managing project timelines, budgets, and deliverables while collaborating with cross-functional teams to ensure products meet the highest standards of safety, efficacy, and quality. Duties and Responsibilities :

• Lead and manage the entire product development lifecycle for Class II and III implantable devices, with an emphasis on women's health applications.
• Ensure that products are launched on time and meet established goals and objectives that support the financial and strategic goals of the organization.
• Ensure all project activities adhere to strict design control practices and regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
• Develop and maintain project plans, including timelines, budgets, and resource allocation.
• Collaborate with clinical, marketing, and regulatory teams to translate user needs into technical product specifications and requirements.
• Oversee the design, development, and testing of implantable mesh products, including material selection, mechanical design, and prototyping.
• Manage the verification and validation processes, including protocol development, testing, and report drafting to support regulatory submissions like Premarket Approval (PMA) and 510(k) applications.
• Conduct and document risk management activities, such as Failure Mode and Effects Analysis (FMEA).
• Provide technical guidance and mentorship to junior engineers.
• Serve as the primary liaison between internal teams and external vendors or suppliers. Required Knowledge, Skills and Abilities :
• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
• 7+ years of product development, program / project management, or engineering experience. Proven experience developing and launching Class II and Class III devices.
• Experience with implantable devices, particularly surgical mesh for pelvic floor disorders or stress urinary incontinence, is highly desirable.
• Direct experience with FDA regulatory processes (PMA and 510(k) submissions) is required. Travel Required : 10-20% Competitive Compensation, Comprehensive Benefits, and more!
• $ 110k-130k 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 holidaysincluding 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 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.