Primary Function of Position:
Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The role requires active participation in manufacturing engineering organization 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.
Roles and Responsibilities:
- 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.
- Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
- Responsible for 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
- 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.
Skill/Job Requirements:
- BS / MS degree in Engineering discipline or equivalent work experience.
- 2+ years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.
- Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
- 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, testing of optical devices, and fiber routing is preferred
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
- Able to travel periodically to suppliers or Intuitive Mexicali plant
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 Employment 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.
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.
