Sr Manufacturing Engineering Manager 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 of Position At Intuitive, we believe that minimally invasive care is life-enhancing care
We are looking for team members with exceptional character who have the capacity to simplify complex problems and the energy to urgently deliver solutions to our patients
We use creative techniques to solve hard problems in order to achieve optimal clinical performance, manufacturabilty and reliability.Within Intuitive, the Single Port robotic platform offers surgeons the ability to perform surgeries through a single incision with boundless possibilities
The Sr
Manufacturing Engineering Manager is responsible for leading and directly contributing to the development of manufacturing processes
This position requires a ‘player / coach’, capable of both strategic technical contributions as well as leadership of a team of multidisciplinary engineers, technicians, and team support members
The role is responsible for a team collaborating with cross functional teams to discover, define, design, develop, and validate new assembly and test processes as well as sustaining and improving them in the achievement of quality, capacity, and cost goals for ISI’s manufacturing operations. The ideal candidate will have experience achieving results working with a team to optimize their potential in being successful.Essential Job Duties Lead a team of manufacturing engineers supporting the process development and commercialization of robotic surgical instruments and accessories products. This includes the full evolution to launch new products and sustain their continued delivery with optimization. Individual contribution working closely with the team will often be required to meet the team deliverables.Establish group & objectives, priorities, and metrics.Ensure the professional development of team members is planned and completed
Plan, budget and staff projects, tracking performance throughout.Interface and effectively 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 priorities are met. Evaluate and challenge designs for technical merit, working with the supply engineering and design teams to realize optimal outcomes.Recognize and attract top talent and invest in mentorship and training to retain and support the career development of team membersFoster an environment that encourages creativity, risk taking, inclusive collaboration, and timely executionNavigate complex technical and programmatic situations driving timely decision making, providing detailed planning and setting appropriate team priorities to achieve successEstablish group targets and personal work goals consistent with overall equipment development and business unit operational goalsManage team generation of formal process development and documentation that facilitates a high quality standard for scalability, and continuous improvement, reviewed cross-functionally, and controlled through product level management release.Review, examine & manage process risk in the manufacturing environment (PFMEA), associated mitigations, critical to quality inputs and controls
Oversee the validation and qualification of manufacturing equipment and processes qualification (IQ/OQ/DQ/PQ/PPQ)Support duplication and line transfersSupports technical investigation and resolution for failure analysis of discrepant components discovered during assembly, assemblies and field returns.Drives continuous improvement initiatives focused on optimum processes, and operational manufacturing line activities (e.g
improvements to process quality, efficiency, performance consistency, capacity, and cost).QualificationsRequired Skills and ExperienceProven capability to manage diverse teams developing processes with manufacturing and test equipment to optimize performance with mechanical, software, algorithms, human interface and electronics aspects.In-depth knowledge of equipment and methods to implement assembly and test processes of complex medical devices.Excellent engineering skills with proficiency in assembly equipment design is required. Must have proven ability in assembly and test process development and integration of equipment to meet process priorities.Excellent mechanical design and analysis skills
Broad knowledge of “First Principles” engineering fundamentals
Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments) in data analysis for process development and problem-solvingProficient in SolidWorks or equivalent CAD softwareExtensive process and fixture design experience, including thorough documentation, reliability, serviceability, and equipment qualificationFundamental understanding of lean six sigma and design for assembly, manufacturing, and automation principles (DfX)Familiarity with medical device reprocessing and sterilization and design of single use products and processesFamiliarity with small part assembly and manufactureA passion for creating high quality robust and reliable productsPersonally motivated to fundamentally understand challenging technical problems and drive implementation of efficient and high quality solutionsDemonstrated knowledge of component manufacturing processes (including injection molding, machining, MIM, advanced 3D printing, heat treatment, and other post-processes)Proven ownership of technical problem solving with ability to identify root cause and drive corrective actionsEffective communication skills (verbal, written, and presentation)Proven people leadership skills – ability to energize and empower a team and unite them in a common goalDemonstrated project leadership and exceptional communication skills to drive assembly equipment, fixturing, and tooling design from development through implementation followed by continuous improvement.Required Education and Training Minimum Bachelors degree in Mechanical Engineering or EquivalentMinimum of 2 years management experiencePreferred Skills and ExperienceMaster’s degree or higher preferred in Mechanical EngineeringMinimum 10 years experience with process development.Experience taking commercial products through entire design, development, and implementation launch cycle.Knowledge of ISO requirements and GMP guidelines. Experience with FDA regulations and medical device design control a plusExperience in manufacturing and assembly automation highly desired.Medical device experience preferred.Additional 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 of Position At Intuitive, we believe that minimally invasive care is life-enhancing care
We are looking for team members with exceptional character who have the capacity to simplify complex problems and the energy to urgently deliver solutions to our patients
We use creative techniques to solve hard problems in order to achieve optimal clinical performance, manufacturabilty and reliability.Within Intuitive, the Single Port robotic platform offers surgeons the ability to perform surgeries through a single incision with boundless possibilities
The Sr
Manufacturing Engineering Manager is responsible for leading and directly contributing to the development of manufacturing processes
This position requires a ‘player / coach’, capable of both strategic technical contributions as well as leadership of a team of multidisciplinary engineers, technicians, and team support members
The role is responsible for a team collaborating with cross functional teams to discover, define, design, develop, and validate new assembly and test processes as well as sustaining and improving them in the achievement of quality, capacity, and cost goals for ISI’s manufacturing operations. The ideal candidate will have experience achieving results working with a team to optimize their potential in being successful.Essential Job Duties Lead a team of manufacturing engineers supporting the process development and commercialization of robotic surgical instruments and accessories products. This includes the full evolution to launch new products and sustain their continued delivery with optimization. Individual contribution working closely with the team will often be required to meet the team deliverables.Establish group & objectives, priorities, and metrics.Ensure the professional development of team members is planned and completed
Plan, budget and staff projects, tracking performance throughout.Interface and effectively 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 priorities are met. Evaluate and challenge designs for technical merit, working with the supply engineering and design teams to realize optimal outcomes.Recognize and attract top talent and invest in mentorship and training to retain and support the career development of team membersFoster an environment that encourages creativity, risk taking, inclusive collaboration, and timely executionNavigate complex technical and programmatic situations driving timely decision making, providing detailed planning and setting appropriate team priorities to achieve successEstablish group targets and personal work goals consistent with overall equipment development and business unit operational goalsManage team generation of formal process development and documentation that facilitates a high quality standard for scalability, and continuous improvement, reviewed cross-functionally, and controlled through product level management release.Review, examine & manage process risk in the manufacturing environment (PFMEA), associated mitigations, critical to quality inputs and controls
Oversee the validation and qualification of manufacturing equipment and processes qualification (IQ/OQ/DQ/PQ/PPQ)Support duplication and line transfersSupports technical investigation and resolution for failure analysis of discrepant components discovered during assembly, assemblies and field returns.Drives continuous improvement initiatives focused on optimum processes, and operational manufacturing line activities (e.g
improvements to process quality, efficiency, performance consistency, capacity, and cost).QualificationsRequired Skills and ExperienceProven capability to manage diverse teams developing processes with manufacturing and test equipment to optimize performance with mechanical, software, algorithms, human interface and electronics aspects.In-depth knowledge of equipment and methods to implement assembly and test processes of complex medical devices.Excellent engineering skills with proficiency in assembly equipment design is required. Must have proven ability in assembly and test process development and integration of equipment to meet process priorities.Excellent mechanical design and analysis skills
Broad knowledge of “First Principles” engineering fundamentals
Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments) in data analysis for process development and problem-solvingProficient in SolidWorks or equivalent CAD softwareExtensive process and fixture design experience, including thorough documentation, reliability, serviceability, and equipment qualificationFundamental understanding of lean six sigma and design for assembly, manufacturing, and automation principles (DfX)Familiarity with medical device reprocessing and sterilization and design of single use products and processesFamiliarity with small part assembly and manufactureA passion for creating high quality robust and reliable productsPersonally motivated to fundamentally understand challenging technical problems and drive implementation of efficient and high quality solutionsDemonstrated knowledge of component manufacturing processes (including injection molding, machining, MIM, advanced 3D printing, heat treatment, and other post-processes)Proven ownership of technical problem solving with ability to identify root cause and drive corrective actionsEffective communication skills (verbal, written, and presentation)Proven people leadership skills – ability to energize and empower a team and unite them in a common goalDemonstrated project leadership and exceptional communication skills to drive assembly equipment, fixturing, and tooling design from development through implementation followed by continuous improvement.Required Education and Training Minimum Bachelors degree in Mechanical Engineering or EquivalentMinimum of 2 years management experiencePreferred Skills and ExperienceMaster’s degree or higher preferred in Mechanical EngineeringMinimum 10 years experience with process development.Experience taking commercial products through entire design, development, and implementation launch cycle.Knowledge of ISO requirements and GMP guidelines. Experience with FDA regulations and medical device design control a plusExperience in manufacturing and assembly automation highly desired.Medical device experience preferred.Additional 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
