Manufacturing Mechanical Engineer

Intuitive Surgical Sunnyvale , CA 94085

Posted 1 week 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

This Manufacturing-Mechanical Engineer (Manufacturing Engineer) position reports to a team responsible for one of the primary devices of the Da Vinci Multi Port Surgical System. In this position, the Manufacturing Engineer utilizes their manufacturing, equipment, and design knowledge to collaborate with design engineering to discover, define, develop, and validate new assembly and test equipment along with assembly process solutions. Their primary focus is to develop assembly and test processes, establish engineering requirements, consider process risks, and identify solutions to guide development. Ultimately, they implement and optimize assembly process equipment, fixturing, and test solutions. They focus on opportunities for poka-yoke, DfX, semi-automated and automated solutions, and design for assembly opportunities to achieve optimal safety, reliability, serviceability, manufacturability, and cost. After production release, and as needed for current released products, they act as the "first line of defense" by providing sustaining support to the manufacturing line while driving continuous improvement of manufacturing processes, equipment, and maintenance procedures. They perform comprehensive failure analysis to identify root cause of emergent production issues, efficiently documenting, mitigating, and closing of non-conformances, and performing requalification of production equipment.

Essential Job Duties

  • Strong mechanical engineering skills with demonstrated proficiency in manual assembly techniques. Mechanical design experience is required.

  • In-depth knowledge of equipment and methods to implement assembly and test processes of complex medical devices.

  • Proven diverse capability to adapt and work with support teams on software, algorithms, electronics aspects of the device, and human interface needs.

  • Proactively evaluates and challenges designs for technical merit, reliability, serviceability, and manufacturability while working with design partners to realize optimal outcomes.

  • Provides a voice for the manufacturing process of Intuitive's products, supplying product and process DfX (Manufacturing, Assembly) input to Product Development Engineering to enhance manufacturability and product cost.

  • Ability to identify and assess potential process risks and mitigations and maintain currency of process FMEA and other quality records.

  • Own and drive continuous improvement of quality, throughput, and cost during development and after product market release. Utilize analytical objective data and statistical analysis to inform and drive decisions.

  • Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, workflows and detailed work instructions. This includes developing the process flow at the unit operation level, creating manufacturing process instructions (MPIs), and developing requirements for processes and test equipment.

  • Supports the validation, qualification, and documentation of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ).

  • Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions and change order creation, review, and implementation.

  • Provides technical support for failure analysis of discrepant production components, assemblies, and field returns. Leads investigations with a cross-functional team to identify root cause, determine mitigations, and drive implementation using tools such as 8D, DMAIC, 5-Why, Fishbones, etc..

  • Committed to delivering top tier manufacturing processes for new products. This includes developing and driving project milestones and schedules, resolving manufacturability issues and root cause analysis, to improvement throughput, yield and efficiency.

  • CAD skillset with vision for electro-mechanical assembly critique and for fixture creation.

  • Designs, document, assemble, implement fixtures and equipment.

  • Provides product and process DFA (Design for Assembly) input to Product Development Engineering to focus on manufacturability and reduce variation.

  • Supports repeatable and efficient "low-volume" manufacturing assembly line, specifying and/or refining BOMs, work flow processes and detailed work instructions.

  • Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions and ECO/NCO/MCO writing, reviewing and implementation.

  • Provides technical support with analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.

  • Participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.

  • Strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.

Qualifications

Skill/Job Requirements

  • 4 yr. degree in Mechanical Engineering.• 3+ years experience as design or manufacturing engineer supporting product with significant mechanical content• Understanding of manufacturing processes including injection molding, machining, stamping and Process Engineering capability• Working knowledge of mechanical assembly, testing, and inspection processes.• Electromechanical new product development experience preferred• Solid modeling/CAD experience (SolidWorks preferred)• Problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments• Excellent communication, organization, follow-up and documentation skills • Comfortable interacting with technicians, engineers, and management all on a regular basis• Technical skills in prototyping, tooling development and troubleshooting • ISO13485 or experience in medical device manufacturing environment• Machine tool experience a plus

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.

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.

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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