Manager Instruments Manufacturing Engineering

Primary Function of Position:

Contribute your technical manufacturing leadership and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. This key technical management role will guide and mentor a talented engineering team responsible for supporting NPI instrument manufacturing by creating manufacturing processes authoring all associated manufacturing documentation dispositioning discrepant material and maintaining compliance with our quality system.

Essential Job Duties

Lead a team of Product Manufacturing Engineers in collaboration with other organizations to support production of complex products with responsibilities including but not limited to:

• Establish group and individual objectives priorities and metrics
• Ensure fulfillment of product development goals for NPI projects
• Ensure the professional development of individual team members
• Ensure production of products meets expected output
• Ensure quality requirements are fulfilled and maintained
• Maintain compliance with medical device quality system including corrective action closure discrepant material disposition and Engineering Change Order (ECO) implementation thru Agile
• Provide technical support for failure analysis and root cause investigation of product failures
• Plan budget and staff projects tracking performance throughout
• Manage and allocate team resources over multiple projects.  Provide and solicit resources to and from other teams as necessary
• Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP) design history file (DHF) and device history record (DHR) guidelines per FDA requirements and support design reviews in accordance with product development procedures
• Improve product quality yields and reduce cost
• Improve the manufacturing process as needed
• Complete cost analysis and lead cost reduction efforts
• Mentor and train new employees
• Create maintain and improve mid-volume manufacturing assembly lines specifying and/or refining BOMs workflow processes manufacturing plan and detailed work instructions.
• 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 (DQ/IQ/OQ//PQ).
• Provide production line support for day-to-day engineering issues on core instrument and NPI lines
• Identify and implement continuous improvement projects with respect to first pass yield cycle time reduction product reliability capacity enhancement and cost reduction.
• Provide technical support analyzing and /or performing failure analysis for discrepant production components assemblies and field returns.
• Other related duties

Qualifications :

Required Skills and Experience

• Successful experience leading projects
• Minimum of five years engineering experience manufacturing complex electro-mechanical products.
• Ability to motivate mentor and inspire a high capacity technical team.
• Prior responsibility for validation of processes equipment and products.
• Strong quantitative process development skills including (p)FMEA tolerance analysis DoE SPC GR&R and CpK.
• Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously.
• Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders including management peers customers and suppliers.
• Experience in an ISO 13485 ISO 9001 or medical device manufacturing environment preferred
• Able to travel periodically to suppliers or Intuitive Mexicali plant

Required Education and Training

• Minimum B.S. degree in engineering discipline M.S. preferred.

Preferred Skills and Experience 

• Experience in an ISO 13485 ISO 9001 or medical device manufacturing environment.
• Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments.
• Prior experience with Class III medical devices
• Familiarity with mechanical CAD (Solidworks) and PLM (Agile) software 
• Experience developing products from early stage concept to volume manufacturing.

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

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

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 compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time