Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Primary Function of Position:
Contribute your technical manufacturing, leadership, and project management skills to a dynamic engineering team developing and manufacturing Instruments and Accessories for minimally invasive robotic surgery. This essential leadership role requires active participation in current engineering projects, that create and refine manufacturing equipment, new manufacturing lines and the qualification of them. Challenging new product designs to improve efficiency, reliability, manufacturability, and cost for robotic surgical instruments and accessories (current products and new products) will be essential to the role. This key technical management role will guide and mentor a talented engineering team responsible for supporting the creation and maintenance of manufacturing processes, authoring all associated manufacturing documentation, dispositioning discrepant material, and maintaining compliance with our quality system.
Roles & Responsibilities:
- Lead a team of manufacturing engineers supporting the production and development of Robotic Surgical Accessories.
- Responsible for the professional development of individual team members.
- Establish group and individual objectives, priorities, and metrics to ensure long term success.
- Mentor and train new employees
- Manage and allocate team resources over multiple projects
- Provide and solicit resources to and from other teams as necessary
- Ensure fulfillment of product development goals for NPI projects
- Ensure production of products meets expected quality and manufacturing objectives.
- Interface and actively participate in post launch activities with product engineering
- Plan, budget and staff projects, tracking performance throughout
- Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation thru Agile
- Work with the 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
- Create, maintain and improve “high-volume” automated and manual manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions
- Review, analyze & manage process risk in the manufacturing environment (PFMEA) & associated mitigation
- Oversee the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ)
- Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns
Skills, Experience, Education, & Training:
- Minimum B.S degree in engineering discipline, M.S preferred
- Minimum of 5 years engineering experience manufacturing complex mechanical products
- Successful experience leading projects
- Fundamental understanding of process engineering, equipment, test and the manufacturing environment “Self-starter” attitude and comfort in a hands-on environment, where he/she can demonstrate an ability to work with other engineers to influence product design to improve reliability
- Ability to motivate, mentor, and inspire a high capacity technical team
- Experience developing products from early stage concept to volume manufacturing
- Mechanical design and analysis expertise desired
- 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
- Familiarity with mechanical CAD (Solidworks) and PLM (Agile) software
- 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
- Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments and accessories is a plus
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
- Able to travel periodically to suppliers or Intuitive Mexicali plant
- 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.
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: $153,100 USD - $220,300 USD
Base Salary Range Region 2: $130,100 USD - $187,300 USD
Travel: 10% of the time
Workplace Type: Onsite - This job is fully onsite.