NPD Engineer

Intuitive•Sunnyvale, CA

About The Position

This role works closely with Mechanical, electrical, Software, clinical, electrical, industrial design, supplier engineering, quality and manufacturing teams to ensure designs of medical equipment meet clinical and user needs and perform reliably and effectively in the field. In this position, you will be part of a team of talented engineers in a focused, high energy, collaborative work environment, challenged to make sound decisions when faced with time pressures and ambiguous or incomplete information typical of issue troubleshooting and product development. You will be expected to use design and analytical skills to conceptualize, develop, and productize product design.

Requirements

3+ years of experience in new product development, product design, manufacturing engineering, or a related engineering role.
Strong hands-on experience with mechanical and electromechanical product development.
Experience developing products from concept/prototype through design transfer and volume manufacturing.
Proficiency in mechanical design and engineering drawing practices, including GD&T, tolerancing, BOM development, and design documentation.
Working knowledge of electrical systems, cable/harness design, connectors, sensors, motors, PCBs, and electromechanical components.
Experience with rapid prototyping, system integration, debugging, and hands-on testing.
Strong understanding of DFM/DFA and manufacturing processes, including machining, injection molding, sheet metal, assembly, and/or cable/harness manufacturing.
Experience working with suppliers and manufacturing partners on component design, manufacturability, quality, and technical issues.
Strong analytical and problem-solving skills with the ability to troubleshoot complex mechanical, electrical, and system-level problems.
Ability to work effectively in a cross-functional, multidisciplinary team environment.
Minimum B.S. Mechanical Engineering, Industrial Engineering or similar with 5 years of experience or Master’s degree plus 3 years.

Nice To Haves

Experience developing products in a medical device or other highly regulated industry.
Experience working within FDA/ISO-regulated product development and quality systems.
Experience with design controls, risk management, verification/validation, and design transfer.
Experience with CAD tools such as SolidWorks or equivalent.
Familiarity with electrical CAD tools and cable/harness design.
Experience developing manufacturing fixtures, tooling, jigs, and assembly automation.
Experience with pilot builds, NPI, production ramp.
Curiosity and excitement to learn new subjects and get to the bottom of tough technical problems.

Responsibilities

Collaborate with multidisciplinary technical teams, Product Development, and Clinical Development to translate clinical, customer, and user needs into engineering requirements, specifications, and product designs.
Lead and support new product development activities across mechanical, electrical, and electromechanical systems from concept through design transfer and commercialization.
Rapidly develop, prototype, test, and iterate full-scale mechanical and electromechanical prototypes to meet product requirements and performance objectives.
Design cables, mechanical components, assemblies, and electromechanical interfaces, and generate detailed engineering drawings, specifications, and documentation suitable for volume manufacturing.
Apply Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Reliability (DFR) principles to develop scalable and cost-effective product designs.
Develop and maintain product documentation including mechanical drawings, BOMs, specifications, assembly documentation, and engineering change documentation within a regulated environment.
Drive system integration builds, debugging, verification, and testing, identifying and resolving mechanical, electrical, and system-level issues.
Develop a strong understanding of overall system architecture, functional interactions, and interdependencies between mechanical, electrical, software, and other subsystems.
Lead and facilitate technical trade-off analyses for component selection, including COTS components, manufacturability, reliability, availability, and risk.
Partner with Manufacturing Engineering and Automation teams to develop fixtures, tooling, assembly processes, and manufacturing methods for new products.
Support the development and optimization of assembly processes and manufacturing equipment to enable efficient and repeatable volume production.
Work closely with suppliers, Sourcing, and Buyers to evaluate component and manufacturing capabilities, resolve technical issues, and ensure designs are aligned with supplier processes and capabilities.
Support design transfer and product transfer to manufacturing, ensuring engineering requirements, drawings, specifications, processes, and documentation are complete and production-ready.
Provide hands-on engineering support during pilot builds, production builds, and product ramp, troubleshooting mechanical, electrical, component, and process-related issues.
Identify root causes of production and component problems and implement corrective and preventive actions to improve product quality, manufacturability, and reliability.
Support verification and validation activities, including test planning, fixture development, test execution, and analysis of results.
Work within applicable quality and regulatory processes, ensuring product development and manufacturing activities comply with company procedures and relevant regulatory requirements.
Participate in design reviews, risk assessments, and cross-functional technical reviews, contributing to FMEA, risk management, and design control activities as required.
Establish and maintain effective relationships with Engineering, Manufacturing, Quality, Regulatory, Clinical, Sourcing, and external suppliers to drive projects toward key milestones.
Help establish and achieve individual and team technical goals aligned with overall project objectives and company strategy.