Manager, Mechanical Design – Equipment

Intuitive•Sunnyvale, CA

About The Position

The Equipment Engineering Manager will be responsible for leading a team of equipment and manufacturing engineers in developing advanced solutions for the production of precision Stapler instruments and accessories used in minimally invasive robotic surgery. This is a key technical leadership role responsible for driving innovation and technology in manufacturing and test equipment design, ensuring compliance with quality systems, and mentoring a highly skilled engineering team. This individual will lead and develop a team of equipment and manufacturing engineers focused on designing, building, and validating custom equipment for precision medical device manufacturing. This role will provide oversight into the entire equipment lifecycle—from specification, concept development and design through implementation and sustained production—while ensuring compliance with quality system requirements and regulatory standards. This position requires close collaboration with cross-functional teams to deliver complex projects on time and within scope. This person will work in collaboration with Product Design Engineering, Supplier Engineering, Systems Analysts, Manufacturing Engineering, Software and Controls Engineering, and Quality Engineering teams to create integrated, scalable production test and processes equipment.

Requirements

BS or graduate degree in Electrical, Mechanical, Mechatronics, or Control Systems Engineering, or similar field.
Successful experience leading teams developing test & process equipment
Minimum of five years’ engineering experience with complex electro-mechanical equipment.
Proven leadership experience motivating, mentoring, and inspiring a high-capacity technical team.
Prior responsibility for validation of processes, equipment and products.
Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK.
Excellent organizational and project management skills; Able to manage multiple fast-paced projects simultaneously.
Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers.
Excellent verbal, presentation, and written communication skills with the ability to relate to different people in cross-functional teams.
Able to lift 50 lbs
Ability to travel periodically (5-10%). Ensuring technology transfer to production sites.

Nice To Haves

MS Preferred.
Have medical device manufacturing experience (GMP, MDD, ISO 13485, ISO 9001, etc.).
Have experience in control systems development for robotics or electro-mechanical systems.
Are familiar with mechanical CAD (Solidworks) and PLM (Agile) software
Have experience with high volume and high complexity manufacturing processes
Have experience with SAP, Windchill and Polarian

Responsibilities

Build and manage a team of mechanical equipment engineers who develop equipment for manufacturing and testing Intuitive’s Multiport Instrument & Accessories products and components.
Responsible for the professional development of individual team members.
Mentor and train new employees
Establish group and individual objectives, priorities, and metrics to ensure long term success.
Establish standards and organize best practices of work for mechanical equipment design engineers.
Manage and allocate team resources over multiple projects
Provide technical leadership for the development of production equipment, test fixtures, and process tools.
Oversee the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ)
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation through Agile
Manage requirements to ensure equipment meets expectations.
Establish standards, metrics, and measurement techniques to assess the quality of equipment delivered by the team.
Collaborate with design engineers, system analysts, manufacturing engineers, and software/controls engineers to ensure that equipment meets requirements.
Identify and implement continuous improvement projects with respect to equipment design, reliability, capacity enhancement and efficiency.
Lead projects within group and/or with cross-functional teams focused on process and equipment improvements for high-volume manufacturing.