Job Title: Lead Product Engineer - Medical Device Job Description The Lead Product Engineer role involves overseeing the design and development process from concept to product transfer and sustaining activities for orthopedic implants and surgical instruments. This includes managing design changes, development phases, validations, and manufacturing optimization, ensuring compliance with FDA regulations and industry standards. The role also includes verifying customized partial implants based on CT imaging, ensuring they meet anatomical design requirements. Responsibilities + Design and develop new products, assembly, and manufacturing processes, including final packaging, from raw material processing to 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 customer needs into target product solutions, concepts, and new product proposals. + Prototype and develop proof of concept designs, disease models, and test methods in a simulated environment. + Ensure all programs and documentation meet rigorous quality standards and regulatory guidelines. + Lead and participate in design reviews and contribute to continuous process improvement. + Collaborate with surgeons, customer service, management, engineering, and machine operators on new product launches and continuous improvement activities. + Create and maintain product CAD, including assemblies, components, and detailed drawings. + Primary support for PFR creation, managing case priority, and ensuring accuracy and surgeon approvals. + Review and edit reconstructed CT imaging to create 3D CAD models of bony anatomy. + Review and edit PFR implant component 3D models using CAD software. + Review and approve bone models, final implant, and associated documentation. Essential Skills + Bachelor’s degree in engineering or technical area with a minimum of 5 years of Product Development and/or CAD/CAM experience in a regulated environment. + Solid understanding of anatomy and bone terminology, industrial design, human factors, and implant design principles. + Track record of successful new product designs reaching commercialization in a regulated environment. + Strong understanding of 3D computer models, point clouds, and reverse engineering anatomy using Mimics software or similar. + Experience with PDM/PLM software, GD&T, and interpreting blueprints, sketches, and drawings. + Strong analytical and problem-solving skills, including root cause analysis and V&V testing. + Experience with Design Control and Risk Management per 21 CFR Part 820. + Mentoring and training experience for junior engineers, technicians, and operators. + Excellent verbal, presentation, and written communication skills. + Acute attention to detail for ensuring medical device safety and quality. Additional Skills & Qualifications + Previous medical device experience, particularly with FDA or EU Regulatory audits. + Lean or Six Sigma certification. + Knowledge of CAM/CNC programming or automation systems. + Highly proficient in Solidworks and PDM. Work Environment Work in a medical device manufacturing company with a history of producing high-quality implantable devices. The environment is highly regulated to ensure compliance with industry standards and safety requirements. Job Type & Location This is a Permanent position based out of Camarillo, CA. Pay and Benefits The pay range for this position is $90000.00 - $120000.00/yr. 401k Holiday vacation Medical dental vision Workplace Type This is a fully onsite position in Camarillo,CA. Application Deadline This position is anticipated to close on Feb 11, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.