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Form of workAs 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.Job Description
Job Description
Contribute your technical manufacturing, leadership, and project management skills to a dynamic engineering team creating precision medical stapling instruments for minimally invasive robotic surgery. This essential leadership role requires active participation in current NPI engineering projects that create and refine robotic instrumentation, 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 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 and Responsibilities:
- Lead a team of manufacturing engineers supporting the process development and commercialization of precision surgical stapling products.
- Establish group & individual objectives, priorities, and metrics.
- Ensure the professional development of individual team members is planned and completed
- Plan, budget and staff projects, tracking performance throughout.
- Interface and actively participate in the design process with DFA, DFX and general manufacturing requirements
- Develop strategic manufacturing & capacity plans for new product introduction
- Responsible for the design transfer process ensuring expected quality and manufacturing objectives are met.
- 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).
- 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
- Responsible for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
Skills, Experience, Education, & Training:
- Minimum BS/MS degree in applicable engineering discipline.
- Minimum of five years of engineering experience manufacturing complex mechanical products
- 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 communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers.
- Troubleshooting/root cause mind set – ability to systematically and effectively break down a system or process into subparts to identify failures
- Experience in application of Lean engineering principles.
- Understanding of Process Capability analysis Strong training and mentoring skills.
- Experience in an ISO 13485, ISO 9001, or medical device-manufacturing environment.
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:$148,300 - $213,500
Base Salary Range Region 2: $126,100 - $181,500
Shift: Day
Travel: 10% of the time
Workplace Type: Onsite - This job is fully onsite.
