Senior Mechanical Engineer - NPD

Intuitive•Sunnyvale, CA

About The Position

This role works closely with clinical, electrical, industrial design, supplier engineering, quality and manufacturing teams to ensure designs of medical capital 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 mechanical designs. Making sound decisions when faced with the time constraints and ambiguous or incomplete information is essential. Lead multi-disciplinary technical teams, working closely with Product Management and Clinical Development to translate clinical and user needs into requirements and specifications for new and current designs. Rapidly develop and iterate full-scale prototypes of candidate architectures to satisfy requirements Design components and produce mechanical drawings in a government regulated environment for volume manufacturing processes which may include cast metal, thermoforming, sheet metal, and others. Develop and commercialize mechanical assemblies, with careful consideration for key functions and safety. Perform risk analyses and develop design requirements. Document and test design according to corporate and departmental operating procedures. Provide technical expertise to assist with the development of initial fixtures and assembly processes in collaboration with manufacturing and automation teams. Support production of final product by troubleshooting process and component problems. Support the quality and regulatory processes. Help establish individual and team goals aligned with overall project and company goals.

Requirements

Experience with mechanical design, including Mechanical analysis, including statics, dynamics, kinematics, stress, fatigue, thermal, and reliability.
Proficiency at failure analysis.
Design, analyze and document components, structures, and mechanical assemblies in SolidWorks or similar CAD software.
Release designs following good documentation principles and configuration control methods.
Experience designing for volume manufacturing processes such as metal casting, plastic injection molding, sheet metal stamping, compression molding, thermoforming, etc.
Self-driven with the ability to excel in a high-energy, small, focused team environment and maintain a strong sense of shared responsibility and shared reward. Contributes to a positive and fun work environment.
Capacity to lead multiple complex projects in parallel. Independently prioritizes activities across projects, ensuring high quality and delivery of the projects.
Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer.
Ability to communicate effectively (written, oral) across all levels and organizations.
BS ME or similar with 6 years of experience or Master’s degree plus 4 years or PhD plus 1 year

Nice To Haves

Experience in designing with a focus on robotics and/or medical products.
Experience in a regulated environment (FDA, Military, FAA or equivalent). Comfortable with execution of design verification/validation test protocols, assessing risk (FMEA), providing inputs to regulatory agency approval including UL, CE and FDA is a plus.
Experience designing for injection molding and extrusion.
Curiosity and excitement to learn new subjects and get to the bottom of tough technical problems.
Proven ability to lead teams, manage stakeholders, and mentor other engineers.

Responsibilities

Lead multi-disciplinary technical teams, working closely with Product Management and Clinical Development to translate clinical and user needs into requirements and specifications for new and current designs.
Rapidly develop and iterate full-scale prototypes of candidate architectures to satisfy requirements
Design components and produce mechanical drawings in a government regulated environment for volume manufacturing processes which may include cast metal, thermoforming, sheet metal, and others.
Develop and commercialize mechanical assemblies, with careful consideration for key functions and safety.
Perform risk analyses and develop design requirements.
Document and test design according to corporate and departmental operating procedures.
Provide technical expertise to assist with the development of initial fixtures and assembly processes in collaboration with manufacturing and automation teams.
Support production of final product by troubleshooting process and component problems.
Support the quality and regulatory processes.
Help establish individual and team goals aligned with overall project and company goals.