Sr Manufacturing Engineer Instruments

Company Description

Job Description

Primary Function of Position:

Contribute your technical engineering, manufacturing and equipment design skills to a dynamic team creating precision electrosurgical instruments for minimally invasive robotic surgery.  The role requires active participation with new product introduction and sustaining manufacturing engineering teams that create and refine robotic instrumentation, new manufacturing lines and the documentation & qualification of them.  Challenging new product designs to improve efficiency, reliability, manufacturability, and cost for robotic surgical instruments will be essential to the role.

Roles and Responsibilities:

• Create, maintain, and improve “mid-volume” manufacturing assembly lines.  Manage and/or refine BOMs, workflow processes, and detailed work instructions.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
• Interface and actively participate in pre and post launch activities with product engineering.  Provide product and process DFx (Design for Manufacturing /Assembly) input to enhance manufacturability and lead improvement implementations.
• Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment.
• Analyze and manage process risk in the manufacturing environment (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 technical support analyzing and/or performing root cause failure analysis for discrepant production components, assemblies, and field returns.
• Responsible for supporting Corrective and Preventive Action projects and resolving quality notifications.
• Responsible for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and Engineering Change Order (ECO) implementation.
• Provide manufacturing line support for day-to-day engineering issues.
• Contribute to the establishment of group and individual objectives consistent with overall product development goals, including priority setting, establishment of metrics, and effectively communicating progress.

Qualifications

Skills, Experience, Education, & Training:

• Minimum BS/MS degree in applicable engineering discipline or equivalent work experience.
• Minimum 5 -7 years of experience as a design or manufacturing engineer supporting product with significant mechanical/electromechanical content.
• Fundamental understanding of process engineering, equipment, test, and the manufacturing environment
• “Self-starter” attitude and comfort in a hands-on environment, where one can demonstrate an ability to work with other engineers to influence product design to improve reliability.
• Troubleshooting mind set - an ability to systematically and effectively break down a system or process into subparts to identify failures and troubleshoot to component level.
• Experience in application of Lean engineering principles.
• Understanding of Process Capability analysis
• Strong training and mentoring skills.
• Proficiency with mechanical CAD software (SolidWorks).
• Excellent documentation skills and ability to communicate effectively both verbally and in writing across all levels of the organization.
• Proven track record of working upstream with product design engineers and can be the voice of manufacturing on product development teams.
• Prior responsibility for process, equipment, or product validation/verification.
• Prior experience designing automated equipment, complex mechanism manufacturing is a plus
• Prior experience with Design Control processes for medical devices and/or clinical applications of surgical instruments, and/or automated equipment design is a plus
• Experience in an ISO 13485, ISO 9001, or medical device-manufacturing environment.
• Able to travel periodically to suppliers or Intuitive Mexicali plant.

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 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.

Base Salary Range Region 1: $130,700 - $188,100
Base Salary Range Region 2: $111,100 - $159,900
Shift: Day
Travel: 10% of the time
Workplace Type: Onsite - This job is fully onsite.