Primary Function:
The Future Forward group within Intuitive Surgical is searching for a Sr. Manager, NPI Manufacturing Engineering to drive the development of manufacturing processes and equipment, to set up the pilot manufacturing line, and to support manufacturing of systems, instruments, and accessories for early feasibility studies and initial launch of a new robotic surgical platform. This role is an exciting opportunity to help define the eventual product from early prototypes through clinical trials and into product launch.
Roles and Responsibilities:
The primary roles of the Sr. Manager will include:
- Provide strategic and technical leadership to the manufacturing engineering team
- Establish group and team member goals, priorities, and metrics to meet organizational needs and assure team member development.
- Establish manufacturing pilot lines for early-stage products for clinical trials
- Set long-term manufacturing strategy for products that scale to commercialization, including:
- Establish BOM structure for efficient production of assemblies and subassemblies
- Establish DFX structure and manufacturing processes to assure products are viable in the long-term
- Support development of strategic supplier partnerships
- Evaluate process automation requirements and equipment
- Define needs for EFT’s and team to develop and support them
- Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation.
- Plan, budget and staff projects, tracking performance throughout.
- Review, evaluate & manage process risk in the manufacturing environment (PFMEA) and associated mitigations. Oversee the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ)
- Work with Quality Engineering group to ensure that 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.
Skill/Job Requirements:
- Minimum B.S. degree in Engineering discipline
- Minimum of 2 years’ experience managing an engineering team.
- Minimum of 10 years’ experience in manufacturing environment for complex electro-mechanical products.
- Demonstrated ability to motivate, mentor, and inspire a high-capacity technical team.
- Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, laser welding, soldering, extrusion, crimping, and other forms of joinery.
- Excellent quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK.
- Familiarity with mechanical CAD (Solidworks), ERP (SAP), PLM (Agile), and ALM (Polarion) software
- Experience with validation/verification of processes, equipment, and products
- Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design
- Exceptional organizational skills and proven ability to work on multiple fast-paced project threads simultaneously
- Clear and efficient documentation skills
- Clear and efficient communication skills
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 / Affirmative Action 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.
EEO and AA Policy
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.
