Primary Function of Position
Contribute your mechanical engineering design and analysis skills to design develop and deploy equipment to test measure and deliver quality instruments and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery.
The role requires active participation in the mechanical manufacturing engineering organization alongside our software engineering counterparts in order to refine electro-mechanical components assemblies process documentation tooling and test methods to improve efficacy reliability manufacturability and cost for surgical robotic instruments.
Essential Job Duties
- Create maintain and improve high-volume 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 instrument-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 on core instrument lines 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 of core instruments.
- Takes responsibility for maintaining compliance with medical device quality system including corrective action closure discrepant material dispositions and ECO implementation.
- Provides technical support analyzing and /or performing failure analysis for discrepant production components assemblies and field returns.
- Able to travel periodically to suppliers or Intuitive Mexicali plant
- 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.
- Conduct SAP transactions relevant to process or equipment operations.
Qualifications :
Required Skills and Experience
- 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.
Required Education and Training
- BS / MS degree in Mechanical Engineering / Mechatronics discipline or equivalent work experience.
- 7 years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.
Working Conditions
None
Preferred Skills and Experience
- Prior responsibility for process equipment or product validation/verification.
- Prior experience designing automated equipment complex mechanism manufacturing is a plus
- CAD experience (preferred Solidworks).
- Knowledge of a wide range of manufacturing processes such as machining injection molding MIM crimping welding and swaging is preferred
- Experience in an ISO 13485 ISO 9001 or medical device manufacturing environment a plus
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Full-time