Sr. Manager, NPI Manufacturing Engineering at Intuitive Surgical
Sunnyvale, CA 94085
About the Job
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.Job DescriptionPrimary 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 teamEstablish 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 trialsSet long-term manufacturing strategy for products that scale to commercialization, including:Establish BOM structure for efficient production of assemblies and subassembliesEstablish DFX structure and manufacturing processes to assure products are viable in the long-termSupport development of strategic supplier partnershipsEvaluate process automation requirements and equipmentDefine needs for EFT’s and team to develop and support themMaintain 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.QualificationsSkill/Job Requirements:Minimum B.S
degree in Engineering disciplineMinimum 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) softwareExperience with validation/verification of processes, equipment, and productsPrior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment designExceptional organizational skills and proven ability to work on multiple fast-paced project threads simultaneouslyClear and efficient documentation skillsClear and efficient communication skillsAdditional InformationDue 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 PolicyWe 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.SummaryType: Full-timeFunction: ManufacturingExperience level: Mid-Senior LevelIndustry: Medical Device
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.Job DescriptionPrimary 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 teamEstablish 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 trialsSet long-term manufacturing strategy for products that scale to commercialization, including:Establish BOM structure for efficient production of assemblies and subassembliesEstablish DFX structure and manufacturing processes to assure products are viable in the long-termSupport development of strategic supplier partnershipsEvaluate process automation requirements and equipmentDefine needs for EFT’s and team to develop and support themMaintain 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.QualificationsSkill/Job Requirements:Minimum B.S
degree in Engineering disciplineMinimum 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) softwareExperience with validation/verification of processes, equipment, and productsPrior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment designExceptional organizational skills and proven ability to work on multiple fast-paced project threads simultaneouslyClear and efficient documentation skillsClear and efficient communication skillsAdditional InformationDue 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 PolicyWe 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.SummaryType: Full-timeFunction: ManufacturingExperience level: Mid-Senior LevelIndustry: Medical Device
