Staff Manufacturing\/NPI Engineer

Moon Surgical•San Carlos, CA

39d

About The Position

We believe the future of the operating room lies in the hands of the empowered surgeon. They are bolstered with complete control, renewed confidence, and technology adaptable to any situation. Our Maestro System delivers this empowerment, resulting in improved operating room efficiency and surgical care for patients - We are using tomorrow's technology to change surgery today. Our blended French-American team is passionate about building this future. Together we are pushing the boundaries in a fast-paced yet focused and deliberate environment. We challenge ourselves often and celebrate our achievements. We believe that communication and planning are as important as execution. We are looking for a Staff Manufacturing/NPI Engineer to join our growing multi-disciplinary team. You will be instrumental in implementing the production processes & design changes needed to bring a next-generation surgical robotics platform to market. This includes the manufacturing, assembly, and testing of all Moon Surgical's systems, sub-systems, and clinical accessories. As an early technology transfer leader for the Maestro System in a growing Operations function, you will: Engage early and often with product development and marketing teams, gaining a deep understanding of product goals and intended use Define end-to-end product workflows for Moon's capital product and key subassemblies Provide DFM and feature optimization feedback to development teams, representing both manufacturing and field service perspectives Identify potential process risks to product quality and develop preventative and detection countermeasures Lead definition manufactured product or raw material acceptance processes and criteria Working with production staff, author and maintain manufacturing work/process instructions and other documents that require QMS controls Define and lead validation efforts related to manufacturing process, equipment, and tools Influence and develop QMS & SOP-level workflows to ensure a right-sized and scalable approach for Moon's product and applications Plan & support builds for prototypes, validations, and pilot runs Lead identification, containment, and corrective actions to manufacturing nonconformances Mentor and lead junior manufacturing and manufacturing engineering staff as the organization grows On a daily basis, you will be working as part of a cross-functional & dynamic team covering various functional areas like R&D, Quality, Regulatory, and external partners. You will be reporting to our VP of Operations who will provide guidance and management on your short-, mid- and long-term projects within the organization through weekly 1-1 meetings. On a daily basis, you will be in contact with all the team members globally, on an as-needed basis, with frequent interactions with management and technical resources. You will be working with input and support from our vendors and consultants. The whole company meets globally a few times a year, and you will rapidly have an opportunity to meet everyone involved.

Requirements

BS or MS in Industrial, Mechanical, Electrical, or Bio Engineering or related discipline
5+ years of experience with manufacturing of complex capital medical devices
Demonstrated experience in New Product Introduction planning and strategy, from concept through execution
Experience with some of the following: injection mold tooling, PCBA / SMT, CNC manufacturing, sheetmetal, electrical and cable management, electro-mechanical assemblies and/or subcontracted assemblies
Experience working with contract manufacturers, suppliers and vendors
A good understanding of Quality Management System elements such as Design Controls, Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), CAPA
Experience with medical device development process, design control, design verification, and regulatory processes
Regular national and international travel required

Nice To Haves

Practical experience in robotics and embedded systems highly desirable

Responsibilities

Engage early and often with product development and marketing teams, gaining a deep understanding of product goals and intended use
Define end-to-end product workflows for Moon's capital product and key subassemblies
Provide DFM and feature optimization feedback to development teams, representing both manufacturing and field service perspectives
Identify potential process risks to product quality and develop preventative and detection countermeasures
Lead definition manufactured product or raw material acceptance processes and criteria
Working with production staff, author and maintain manufacturing work/process instructions and other documents that require QMS controls
Define and lead validation efforts related to manufacturing process, equipment, and tools
Influence and develop QMS & SOP-level workflows to ensure a right-sized and scalable approach for Moon's product and applications
Plan & support builds for prototypes, validations, and pilot runs
Lead identification, containment, and corrective actions to manufacturing nonconformances
Mentor and lead junior manufacturing and manufacturing engineering staff as the organization grows