Staff Mechanical Engineer - Equipment

Intuitive•Sunnyvale, CA

About The Position

Contribute your technical skills to design and develop manufacturing equipment for the Multiport Accessories Process Engineering organization, with a focus on high-volume automation. The candidate will take responsibility for equipment development from initial concept and detailed mechanical design through fabrication, testing, qualification, and release to production. The candidate will design and develop in-house proprietary manufacturing equipment and will also evaluate external automation suppliers, define detailed equipment specifications, and provide technical oversight to OEMs. The candidate must demonstrate strong mechanical design fundamentals, sound engineering judgment, and the ability to coordinate within cross-functional teams. They must excel in a high-energy environment and be capable of making sound decisions when faced with time constraints and incomplete information.

Requirements

Experience with high volume automation lines.
Fundamental understanding of process engineering, equipment, test and the manufacturing environment
“Self-starter” attitude and comfort in a hands-on environment, where he/she can demonstrate an ability to work with other engineers to influence product design to improve reliability
Demonstrated experience designing and releasing manufacturing equipment or complex automated systems into production.
Proficiency in 3D CAD and engineering drawing development. SolidWorks experience is preferred.
Strong understanding of mechanical design, mechanism development, GD&T, tolerance analysis, material selection, and manufacturing processes.
Ability to integrate mechatronic components such as robotics, sensors, motors, pneumatics, motion control, and machine vision systems.
Experience developing equipment requirements and detailed technical specifications for automation OEMs or system integrators.
Experience reviewing supplier concepts, designs, drawings, component selections, and equipment acceptance plans.
Experience with equipment qualification, process validation, and regulated quality systems.
Strong analytical, troubleshooting, project execution, and technical documentation skills.
Excellent written and verbal communication skills.
Self-motivated, able to take initiative, and effective in a multidisciplinary team environment.
BS/MS degree in Mechanical engineering or a related engineering discipline.
Minimum of eight years of relevant experience developing manufacturing equipment or automation systems.
Direct experience in medical device manufacturing is required.
Staff-level consideration will require additional technical depth and demonstrated leadership of complex equipment or automation projects.

Nice To Haves

Experience in an ISO 13485 regulated medical device manufacturing environment.
Experience designing equipment for high-volume assembly of medical devices or precision products.
Experience managing internally designed equipment and externally sourced turnkey automation systems.
Experience with OEM selection, technical bid evaluation, design reviews, factory acceptance testing, site acceptance testing, and production qualification.
Familiarity with design controls, risk management, engineering change control, and equipment validation.
Experience with Windchill and Agile product lifecycle management systems is a strong plus.
Experience mentoring engineers or establishing equipment design standards and engineering best practices.

Responsibilities

Design and develop in-house manufacturing equipment, automation systems, tooling, and fixtures from concept through release to production.
Translate manufacturing process needs into detailed equipment requirements, specifications, and acceptance criteria.
Develop 3D models, engineering drawings, tolerance analyses, bills of material, and supporting technical documentation.
Integrate mechanical designs with robotics, sensors, motors, pneumatics, motion control, machine vision, and safety systems.
Evaluate and select OEMs and system integrators based on technical capabilities and project requirements.
Develop detailed specifications for externally sourced automation equipment and provide technical oversight through design, build, testing, installation, and qualification.
Lead equipment design reviews, risk assessments, troubleshooting, and technical problem-solving activities.
Guide equipment projects through applicable design control, engineering change, qualification, and release processes.
Develop equipment testing strategies, acceptance criteria, qualification protocols, maintenance requirements, and calibration procedures.
Apply Cpk, Gauge R&R, tolerance analysis, and other statistical and quality tools to improve equipment capability and reliability.
Provide equipment-related technical support for production operations, continuous improvement, capacity expansion, and equipment lifecycle management.
Provide technical guidance and mentorship to engineers, technicians, and cross-functional project team members.