NPD Engineer

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Intuitive in Sunnyvale, CA is seeking an accomplished engineer to design and bring medical devices from concept to production. You will collaborate with mechanical, electrical, software, clinical, and manufacturing teams to ensure robust, reliable products.

The role emphasizes fast prototyping, DFx, documentation, and helping scale from pilot builds to volume manufacturing, with a focus on safety, quality, and regulatory compliance.

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 development and optimization of assembly processes and manufacturing equipment to enable efficient 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.

Job description

Job Description

Essential Job Duties
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.

• 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.