Senior Project Engineer

Senior Project Engineer – Westlake Village, CA100% 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.ResponsibilitiesLead 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 AbilitiesBachelor’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%Compensation and Benefits:$110k-130k Annual SalaryMedical and Dental Benefits – 75% paid for employee and family membersVision Coverage401(k) with 4% matching contributions after 90 days of employmentBasic Life and AD&DUnlimited Vacation Policy6 Weeks Paid Maternity Leave10 paid holidays – including your birthdayBeing surrounded by amazing peopleNote: This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position.Our CultureA culture of family and team, not a corporate environment where you/'re just another number.All employees have a seat at the table and influence with management. We care about giving back to the community and donate time to helping local charities throughout Southern California.The Women’s Health Initiative is the core of what we do, and we prioritize underprivileged women.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 on Inc 5000’s fastest growing private companies list and recognized for growth in the Los Angeles area. We develop and market differentiated surgical implants for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse, 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. #J-18808-Ljbffr

Created: 2025-09-29