Senior Design Engineer Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women! Caldera Medical is seeking a Senior Design Engineer to join our amazing team and support our mission to improve the quality of life for women. Caldera Medical has invested in both organic and inorganic product portfolio development with the goal of becoming a global leader in the women's health industry. As part of this portfolio growth, it is essential to have a strong and experienced R&D team capable of creating, launching, and maintaining both new and existing products. This role is critical in designing and developing product solutions that elevate women's healthcare. The position will provide design leadership for new product development projects, as well as all sustaining engineering activities. Successful candidates must be reliable, friendly team players with the ability to multitask, communicate effectively, and prioritize/manage time efficiently. Duties and Responsibilities: * Work with marketing to translate customer requirements into tangible requirements. * Lead the design of new product concepts based on customer requirements. * Identify appropriate material of construction for new designs based on functional requirements. The materials of construction include but are not limited to metals, polymers, polymer-metal blends and can be formed by various methods including but not limited to injection molding, stamping, extruding, machining, 3D printing. * Design and develop new products and related assembly and manufacturing processes. These processes range from raw material processing through final device assembly. Provide technical leadership for all new product projects and sustaining R&D activities. * Responsible for all technical stage/gate deliverables for new product development. * Translate voice of customer needs into target product solutions, concepts, and new product proposals. * Prototype and develop proof of concept designs, disease models, and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs. * Execute a long-term strategy for examining new designs, materials as well as processing methods for current & next-generation hysteroscopy products. * Work with IP counsel to identify and implement product patent strategies. * Generate and execute test methods to characterize designs and to establish root cause of design, manufacturing, or material defects. * Create and maintain product CAD, including assemblies, components, and detailed drawings. * Observe clinical cases and participate in interviews with clinical experts to inform designs. * Assist in managing and directing outside research and development projects for broader insights. * Lead and participate in design reviews, contributing to the continuous improvement of our processes. * Identify and support component and process vendors, enhancing our supply chain effectiveness. * Guide engineering and laboratory teams in prototyping, manufacturing, and testing, fostering a culture of collaboration and growth. * Assist in managing and directing outside research and development projects for broader insights. Required Knowledge, Skills and Abilities: * 8+ years of product design and development including early-stage concept and technical feasibility in biomedical engineering and/or the medical device industry. * Possesses in-depth knowledge and experience in the disposable medical device design and manufacturing industry. Prefer experience with electromechanical design & regulations (60601). * Track record of success with new product designs reaching commercialization in a regulated environment. * Strong Medical device concept development, prototyping, and testing experience. * Strong Medical device design and manufacturing knowledge and experience. * Working knowledge of Electrosurgical design and regulatory requirements. * Highly efficient in Solidworks. * Effective verbal, presentation and written communication skills. * Medical Device product launch experience. * Ability to travel up to 15-20%. 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. 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 2025! Competitive Compensation, Comprehensive Benefits, and more! * $130,000.00 base 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! Hear it from our very own! Learn more about Caldera on Glassdoor The description above represents the most significant duties of this role but is not all inclusive. Other work assignments comparable to the level of responsibility indicated above may be required. 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.