Intuitive Surgical Inc Hiring For Manager, Vision Illuminator R&D at Sunnyvale, CA Full Time

Company Description
At 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 Description

Primary Function of Position:

The Manager of Vision Hardware R&D will be responsible for leading a team of engineers who a) contribute towards the next generation vision illumination systems, b) devise engineering test methods for engineering product evaluations and characterization.  This role is a key part of making data driven decisions to improve product designs prior to launch in addition to improving existing production released hardware. The role will be leading cross functional teams for development on current and new products.

Roles and Responsibilities:

This key technical management role will guide and mentor a talented R&D engineering organization responsible for owning and developing the next generation of electro-opto-mechanical product designs.  They will work with their team on devising robust engineering test methods for product evaluations and characterization for endoscope controllers, illuminators, and interfaces. The team shall work closely with the electrical, optical, and other mechanical teams to collaboratively develop these novel designs.

This role will flex between the areas listed below, based on project needs and candidate strengths.  Skillsets in all areas are preferred, however candidates with skillsets in two or more areas will be considered:

• Requirements: Interface with clinical, usability, I&A design, systems analysis, and interfacing design teams to develop, negotiate, decompose/establish trace relationships for, and substantiate illumination and endoscope interaction requirements.
• Risk:  Lead the team to discover failure modes and characterize design feature candidates to advance understanding of safety, performance, and business risk. Drive failure investigations, manage the agenda, drive experimental approach, and execute experiments.
• Design Feature Integration and Testing: Own design feature integration efforts with team, to advance the development of the full device.  Lead the team through product development and testing to explore interactions between features and relationships between behavior of individual features vs the full device performance. Drive tradeoff decision making through use of said requirements and understanding of said risk and design feature interaction.
• Test: Drive the development of new methods or improve existing test methods to enable rigorous risk characterization and failure mode discovery. Tasks include leading the team through designing and building custom test fixtures / setups, clinical relevance substantiation, automation as applicable, and stratification of test conditions.
• Additional duties:
  • Provide technical leadership to the Vision R&D Engineering organization
  • Lead, and be responsible for novel product development work on endoscope illuminators, and test method development for illuminators and endoscopes
  • Analyze the current product performance, to identify opportunities for design improvements and implement changes
  • Establish group and individual objectives, priorities, and metrics to:
    • Communicate results to stakeholders or in formal documentation when appropriate.
    • Ensure fulfillment of current customer demands
    • Ensure progress towards Product Development goals
    • Ensure reliability and efficiency improvements of existing products
    • Ensure the professional development of individual team members
  • Collaborate with the Endoscope and Systems design teams on multiple platforms, New Product Introduction (NPI) and Manufacturing teams to implement required manufacturing processes (Equipment, Manufacturing Instructions, Travelers, etc.)
  • Maintain compliance with medical device quality system, discrepant material disposition and Engineering Change Order (ECO) implementation.
  • Lead cross functional team(s) in our Product Development Process (PDP) including: generating formal design documentation, review, and control (e.g. design reviews, ECOs, etc.), test method development, compliance with applicable local standards
  • Work with cross functional development team (RA/QA/ME/NPV/CDE) to develop and manage project contracts, including: project plans, budgets, managing timeline, risks and issues to meet customer and business goals
  • Plan, budget, and staff projects, tracking performance throughout.
  • 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.
  • Clearly define and motivate unmet needs and their context in the marketplace.
  • Coach, develop and manage the engineering team through influential leadership, balancing the development objectives of the team with the needs of the organization.

Qualifications

Core Competencies, Skills and Experience Requirements:

• B.S. degree in Engineering discipline, M.S. preferred.
• Minimum of 8 years’ of direct experience managing/mentoring engineers is preferred
• Minimum of 10 years’ experience in design, manufacturing, or service environment for complex electro-mechanical products.
• Experience with medical device design and interface design is preferred.
• Track record of leading and developing sustainable teams.
• Knowledge of ISO requirements and GEP/GMP guidelines.
• Familiarity with sterilization processes and design guidelines for sterilization and reprocessing
• Familiarity with small part assembly and manufacture
• A passion for creating robust and reliable products
• An excitement to get to the bottom of challenging technical problems
• Proven ability to maintain schedule while bringing products from concept to manufacturing introduction.
• Strong mechanical engineering intuition
• Track record as a systems level architect and demonstrated ability to lead teams to realize the architectural vision
• Ability to motivate, mentor, and inspire a high capacity technical team.
• Prior responsibility for validation of products is a plus.
• Strong quantitative process development skills including (d)FMEA, (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK.
• Familiarity with mechanical CAD software (Solidworks).
• Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously.
• Prior experience with Agile Change Control and SAP is a plus.
• 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 is a plus
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred

Shift : Shift 1 – Day

Travel : Yes, 10 % of the Time

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits and equity, and the anticipated pay rate for this position is $157,300 to $226,300. 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 location, skills, and experience level.

Additional Information

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.

Shift : Day

Travel : 10% of the time