Sr Supplier Process Engineer, Electronics

Sunnyvale, CA
Permanent
Full-time

17 days ago

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:Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers. Guide Engineering in choosing suppliers for new products and providing DFM input to new designs. Supports both NPI and ongoing production, monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.The ideal Candidate has a track record of supporting new products launch, demonstrated collaboration with Contract Manufacturers, and preferred experience with multiple manufacturing methods, including various metal/plastics machining processes, treatments, and finishing processes. Plastic Injection Molding and Metal Injection Molding are preferred as well. The candidate also has skills in selecting and developing suppliers.Roles & Responsibilities:

Complete Part Qualification (PPQP) deliverables, including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis
Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation.
Select the right process and supplier for the part, considering long-term fit and total cost of ownership.
Manage supplier changes, including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process.
Own and drive to closure supplier variances from symptoms through root cause analysis to corrective action, including careful CAPA documentation.
Effectively prioritize and advance multiple concurrent projects and tasks
Clearly communicate project status to key stakeholders
Build, own, and relentlessly pursue a vision for developing suppliers.
Understand the proper level of documentation detail for tracking of actions and justification of decisions.
Generate key metrics for the team and suppliers and continually drive for the timely achievement of those metrics.
Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive's requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC, and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously.
Implement corrective and preventive actions for the supplier process by driving the supplier's investigations and root cause analysis.
Work with suppliers and ISI engineering for the new product introduction to:

Create product supplier landscapes to determine launch readiness and report to management.
Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
DFM by engaging suppliers early in the development cycle to provide feedback on manufacturability improvements in the designs prior to production.
Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.
Review, analyze, and close customer complaints, manufacturing variance requests, and first-article inspections by judging risk analyses and justifications.
Evaluate corrective and preventive actions at suppliers and look for opportunities with suppliers to eliminate recurrence.

QualificationsSkills, Experience, Education, & Training:

Minimum 8 years related experience with a BS Engineering degree or 6 years' experience with an MS in Engineering
Excellent written and verbal communication skills, including presentations to executive-level management.
Excellent Interpersonal skills and team-building skills.
Excellent Project Management skills.
Excellent analytical and problem-solving skills along with good judgment.
Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
Demonstrable knowledge of a wide range of manufacturing processes, including understanding of key input variables for quality, cost, and capacity (Machining, Plastic Injection Molding, Metal Injection Molding, and/or knowledge in Contract Manufacturing)
Proven ability to lead teams to solve difficult technical and process problems
Proven ability in New Product Introduction and rapid scaling in production
Proficient in pFMEA, process validation, root cause investigation, inspection, and test techniques
Knowledge of document management systems and ERP Systems, preferably Agile and SAP
Knowledge of 21 CFR part 820 and ISO 13485 preferred
Excellent written and verbal communication skills, including presentations to executives
Experience in a high-volume medical device company is a plus
Ability to travel to suppliers on an as-needed basis - domestic and international (approx. 25%)

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 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.

Intuitive Surgical

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