Lead Product Engineer - Medical Device

Description

Lead Product Engineer role is responsible for executing the main elements of Design from concept through Product Transfer and some on-going sustaining activities for orthopedic implants and surgical instruments as it relates to design changes. Including all phases of development, validations (equipment and product), and optimizing manufacturing processes and systems to ensure compliance with FDA regulations and ISO 13485 standards. Primary support engineer for verifying customized partial implants for patients based on CT imaging. This role is responsible for ensuring anatomical designs from CT imaging matches patient and surgeons’ requests by ensuring accuracy, high-quality, patient-specific patella femoral knee implants and instruments for successful implantation. Key responsibilities: Design and develop new products and related assembly and manufacturing processes including final packaging. 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, traceability matrix and verification and validation activities. Work within a regulated medical device environment, ensuring all programs and documentation meet rigorous quality standards and regulatory guidelines, such as FDA and ISO requirements. Lead and participate in design reviews, contributing to the continuous improvement of our processes & monitor key performance indicators (KPIs). Collaborate with Surgeon, Customer Service, Management, Engineering, and machine operators on new product launches, continuous improvement activities to ensure designs are manufacturable and to troubleshoot any issues. Create and maintain product CAD, including assemblies, components, and detailed drawings. Primary support for PFR creation, manage case priority according to need date and PFR accuracy and surgeon approvals, and associated documentation. Review and edit reconstructed CT imaging using software such as Materialise Mimics 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.

Skills

Medical device, New product development, CAD, 3d design, 3d modeling, CT image, bone anatomy, implant design, risk management, 13485, 21 cfr part 820, Solidworks, Product design, Mechanical engineering, Autocad, Validation, PDM, PLM, GD&T, prototype, r&D, test method, root cause analysis, 14971, blueprints, euMDR, regulatory audits, FDA, Lean, six sigma, industrial design, bone terminology, Mechanical design, Development, Design, Product engineering, PFR, traceability matrix, windchill

Top Skills Details

Medical device,New product development,CAD

Additional Skills & Qualifications

Required: Bachelor’s degree in engineering or technical area and 5 years minimum of heavy Product Development and/or CAD/CAM experience in a medical device or highly regulated environment. Solid understanding of anatomy and bone terminology, Industrial Design and Human Factors and applying specific knowledge of implant design principles, biocompatible materials, and surgical requirements Track record of success with new product designs reaching commercialization in a regulated environment. Strong understanding of 3D computer models & point clouds to reverse engineer anatomy from CT images using Mimics software or similar. Understanding of PDM/PLM software, Geometric Dimensioning and Tolerancing (GD&T), read and interpret blueprints, sketches, drawings, and rapid prototyping processes Strong analytical and problem-solving skills including root cause analysis, V&V testing, and statistical analysis, and specification writing. Experienced with Design Control and Risk Management per 21 CFR Part 820, ISO 13485, ISO 14971. Experience mentoring and training junior engineers, technicians, and operators Strong Team player with effective verbal, presentation and written communication skills. Acute attention to detail is critical for ensuring the safety and quality of medical devices. Preferred: Medical device experience: Previous experience with FDA or EU Regulatory audits is desired Lean or Six Sigma certification is desired Knowledge of CAM/CNC programming or automation systems Highly efficient in Solidworks and PDM.

Experience Level

Expert Level

This is a Permanent position based out of Camarillo, CA.

The pay range for this position is $90000.00 - $120000.00/yr.

Medical vision dental 401k

This is a fully onsite position in Camarillo,CA.

This position is anticipated to close on Dec 31, 2025.

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 for other accommodation options.

Salary : $90,000 - $120,000