Manufacturing Engineering Manager

Primary Function of the Position

Lead team responsible for Process Development, Design Transfer, and Production Support.  Actively participate in the development and refine of assemblies, manufacturing processes, associated tooling, and test methods.  Deliver the product on schedule and on budget by employing core capabilities including project management, process development, lean manufacturing, and team play.  Continue to improve and support production, and delivery of quality product to the customer.  

Essential Job Duties

• Ownership through the complete lifecycle from process development, process validation, full production ramp, sustaining, and end of life.
• Drive creation of efficient manufacturing assembly line, specifying and refining assembly and test processes, workflows and detailed manufacturing instructions (MPIs).
• Manage and allocate team resources over multiple projects.  Negotiate for needed resources to enable project/program success.
• Evaluate and present production capability, status, risks, and mitigations at product development focal reviews.
• Drive team to plan and satisfy goals focused on vital few organizational needs. 
• Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation through Agile.
• Creating budget estimate for new product introduction resources, prototype materials, tooling and engineering tests.
• Must possess strong written and verbal communication skills to interface with management peers, suppliers, and a host of ISI organizations including, new product development, planning, purchasing, quality, regulatory, inspection, and marketing. 
• Ensure the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.

Required Skills and Experience

• Demonstrated Mechanical and Process Engineering ability
• Demonstrated ability in failure analysis and continuous improvement
• Demonstrated ability to represent the company to its partners, suppliers, and vendors

Required Education and Training

• BS degree in an engineering applicable discipline.
• 5+ years of engineering experience in manufacturing electro-mechanical products.

Working Conditions

• None

Preferred Skills and Experience  

• MS degree in mechanical or industrial engineering
• Experience in Medical Device Manufacturing (including GMP, MDD, ISO) – a plus
• Experience with Lean Manufacturing and/or 6-Sigma techniques – a plus

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 employees
who 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 government’s 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 employee’s
start 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.