Product Development 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 Product Development Engineer to join our amazing team and support our mission to improve the quality of life for women. The Product Development Engineer will be responsible for supporting both new and sustaining R&D product development activities. This role includes providing project management and design control support for new product development projects, as well as all sustaining engineering activities. The ideal candidate will have experience in medical device component and material processing, design, and manufacturing. 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 * Assist with design of new product concepts based on customer requirements * Support the Design and development of new and existing products and related assembly and manufacturing processes * Work directly with Regulatory and Quality consultants to complete/satisfy all design control deliverables required for the communicated regulatory strategy and submissions * Work directly with manufacturing to complete/satisfy all manufacturing deliverables for each new and sustaining engineering objective * Own Design FMEA(s) and drive cross-functional participation for these documents * Coordinate/write protocols as required to Develop/Document all testing protocols for V&V and customer input * Coordinate and complete the following as needed for all new development and sustaining engineering objectives: * Project Schedule * Quality and Regulatory documents * Labeling and IFU changes * Design Requirements - Trace Matrix * Design Specifications - Trace Matrix * Real Time Aging retention, testing * V&V testing, documentation * Testing protocols and reports * Support Engineering Evaluation of returned product when needed * Competitive product evaluation including standard testing * Support change Orders, technical review, implementation when needed * Remain current with all internal and appropriate external developments and policies in related areas of activity. * Provide other department support as requested by immediate supervisor or senior management. * Interface with vendors and manufacturing as required when implementing new designs and/or completing sustaining engineering changes. * Provide input as required related to the intellectual property strategy for new and existing designs. Desired Knowledge, Skills and Abilities: * Prefer Bachelor level degree in Engineering / Technology. * At least 2-3 years of design control and/or quality system experience in a regulated industry, preferably medical devices. * Experience in medical device component and material processing, design, and manufacturing. * A comprehensive understanding of ISO, GMP and FDA regulations for the development. * Experience in the commercialization of medical devices in the U.S. and global, is preferred. * Strong analytical and problem-solving skills and comprehensive understanding of design control processes and validation of processes and designs. * Proven project management skills. * Effective verbal, presentation and written communication skills. * Proficient in Microsoft Office, and MS project. * Working experience in Solidworks. * Working knowledge of medical device development, sterilization requirements and techniques, and medical device regulations. * Ability to travel up to 10-20%. Who is Caldera Medical? Caldera Medical is a growth stage medical device company focused on designing, manufacturing, and marketing products into the Gynecology, Urology and Urogynecology surgical markets. We are searching for highly motivated, dynamic and results oriented individuals to join us in improving the quality of the patients we serve. Competitive Compensation, Comprehensive Benefits, and more! * $80,000 base salary * Basic Life and AD&D * Unlimited Vacation * 6 Weeks Paid Maternity Leave Supplement * Being surrounded by talented and engaged employees * Medical / Dental Benefits - 75% paid for employee and family members * 401(k) with 4% matching contributions 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.