
Sr Manufacturing Engineer, Automation Equipment
- Sunnyvale, CA
- Permanent
- Full-time
Contribute your engineering design and analysis skills to design, develop and deploy equipment to test, measure, and deliver quality products and project management skills to a dynamic manufacturing engineering team creating precision instruments & electrosurgical equipment for minimally invasive robotic surgery.
The role requires active participation in the manufacturing engineering organization alongside our design and software engineering counterparts to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic platforms and products.Essential Job Duties
- Create, maintain and improve manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
- Design, document, procure, qualify, implement, and improve fixtures, tools and equipment which includes hardware (mechanical and electronic components) and software (control algorithms and programming).
- Independently and proactively determines and analyzes data trends for equipment performance to root cause equipment issues to ensure accuracy, reliability, repeatability, and reproducibility of equipment.
- Analyze manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
- Responsible for (author, execution, and training) the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
- Provide production line support for day-to-day engineering issues i.e. resolve emergency and unscheduled problems/repairs of equipment.
- Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
- Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability.
- Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
- Demonstrate leadership through knowledge transfer, mentoring, and training of others
- Proactively seeks better and improved technologies for improving production processes
- Provide resource planning and budget estimates for product and process improvements, tooling development, and testing
- Improve existing documentation for equipment installation, repair, and upkeep.
- Responsible for review of peer edits to documentation of fixtures, tools, and equipment.
- Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
- Strong technical analytical and troubleshooting skills.
- Prior experience with managing product and process changes.
- Strong organizational skills and proven ability to work on fast-paced projects simultaneously.
- Prior experience with technical writing.
- BS / MS degree in Mechanical Engineering / Electrical Engineering / Mechatronics discipline or equivalent work experience.
- 7+ years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.
- Prior responsibility for design of equipment, process or product validation/verification.
- Prior experience designing automated equipment, complex mechanism manufacturing is a plus
- Proficiency using CAD to design and document mechanisms; SolidWorks preferred
- Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, testing of optical devices, and fiber routing is preferred
- Experience with electrical circuit design and testing is a strong plus
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus