Sr Medical Device Development Engineer

Intuitive Surgical Sunnyvale , CA 94085

Posted 2 months ago

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:

Accessories often serve as the interface between other aspects of the da Vinci system and enable safe and effective robot-assisted surgery. They may be reusable or single-use medical devices (consumables), with yearly volumes in the millions. Our customers interact directly with accessories in every surgical procedure, and they serve a critical role in customer satisfaction and patient outcomes.

We are looking for a hands-on, technically strong mechanical engineer to sustain and improve existing Accessories to meet the needs of our customers and our business, and to support development, testing, and documentation of new product designs.

The Sr Medical Device Development Engineer will work on product development of a variety of Accessories. The successful candidate must excel in a fast-paced team environment and be capable of creative problem solving when faced with the time pressures and design constraints typical of product development. She or he must have a strong sense of ownership, shared responsibility, commitment to high product quality and be comfortable collaborating across organizational boundaries. Projects will include a mix of new product development, product improvements, cost savings and manufacturing improvements to enable significant volume growth.

Roles and Responsibilities:

  • Provide mechanical engineering sustaining support for resolution of manufacturing and field issues:

  • Characterize sources of variations in product performance and implement mitigations accordingly.

  • Investigate and determine root cause of design, manufacturing, or material issues.

  • Resolve complex engineering challenges through hands-on product testing and collaborate with subject matter experts both internal and external to organization.

  • Design, develop and document components and assemblies for surgical system accessories:

  • Create product functional and design specifications.

  • Create, analyze, and test product designs and their components.

  • Research, understand and design to relevant product specific standards.

  • Develop, implement, test, and document solutions that meet clinical, functional and product requirements.

  • Designing for manufacturing and automation, sterilization processes and biocompatibility.

  • Support and participate in clinical and human-factor evaluations for new designs or design changes to ensure positive user experiences.

  • Provide mechanical engineering expertise to support continuous production of high-quality surgical accessories to our customers:

  • Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of designs into production.

  • Work within multi-disciplinary teams to define requirements for new and current designs.

  • Develop mechanical assemblies, with careful consideration for key functions and safety while designing for manufacturability, reliability, and cost.

  • Develop components and product mechanical drawings in a regulated environment for high volume manufacturing processes, including plastic injection molding, thermoset compression molding, machining.

  • Develop Design History Files per FDA requirements.

  • Contribute to the determination of future product release content.

  • Help establish individual and team goals aligned with overall project and company goals.

Qualifications

Skill/Job Requirements:

  • Minimum BSME required, MSME preferred.

  • Minimum 7 years of medical product experience (Prior sustaining experience in high volume product preferred)

  • A passion for solving tough technical problems - Strong mechanical intuition and persistence to drill down to pinpoint root cause of problems, solving problems using fundamental principles.

  • Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements.

  • Demonstrated knowledge of materials (preferably plastics, silicones, isoprenes) and material properties. Ability to apply knowledge of engineering materials and component selection criteria to product designs through strong concept development, design analysis, hands-on prototyping, and reliability testing skills.

  • Familiar with various packaging and sterilization methods

  • Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; Solidworks strongly preferred.

  • Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer.

  • Comfortable with concepts of design input, design output, traceability, and risk analysis

  • Ability to communicate effectively and accurately (written and oral) across all levels and functions, including presenting to a technical audience.

  • Strong desire to mentor junior engineers.

  • Ability to travel up to 10%

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.

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.


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Sr Medical Device Development Engineer

Intuitive Surgical