Company Description

Job Description

Primary Function of the Position
The Senior/Staff NPI Manufacturing Engineer, Advanced Energy (Catheter/Instruments), is responsible for the transformation of advanced energy products from early phase R&D to clinical manufacturing. Their focus will be on the creation of new clinical pilot lines, process development, and build readiness contributing to the exploration of novel system concepts for new applications of surgical robotics. They will be a responsible member of the Future Forward team supporting innovative technology development and long-term commercialization. They will have both the technical depth to resolve complex mechanical, material, and manufacturing design issues as well as the ability to work in an interdisciplinary team to troubleshoot and root cause higher level system issues. They must have strong technical depth in relevant areas and have a track record of successful manufacturing & process development efforts. Using their subject matter expertise, exceptional communication skills and cross-functional collaboration, they will work closely with the design team to bring advanced energy applications for novel clinical applications to fruition across our robotic surgical systems.

They must excel in a high-energy, focused, small-team environment, be able to deal with high levels of ambiguity and have a commitment to achieving high quality products. A strong sense of shared responsibility and shared reward is required.
Responsibilities

• Assess manufacturability of current designs and identify critical steps for further process development
• Define pilot manufacturing lines for system components, instruments, and accessories, order equipment, and bring up the line
• Develop NPI strategy for supporting verification and validation of product
• Manage suppliers and vendors to produce components, assemblies, and/or prototypes
• Build and maintain top level assemblies in Agile document control system
• Design, specify, purchase, build, and qualify aids and test equipment for the line as necessary
• Manage completion of all manufacturing documentation in support of clinical studies or launch
• Support the design team with product development activity including, but not limited to, component development, design investigations, component/product testing, and concept development.
• Support the design team with builds for prototypes or pre-clinical studies as required
• Hands-on assembly and testing of equipment and devices to support proof of concept, design development, pre-clinical and V&V activities
• Perform tests, critically analyze results, and make design changes or recommendations to the design team 
• Investigate and determine root cause of emerging design, manufacturing, or material defects
• Development and documentation of design and manufacturing documentation including inspection procedures, assembly instructions, test methods, purchase specifications, BOMs, part and assembly drawings using appropriate change control procedures
• Establish individual goals consistent with overall project goals

OTHER

• Keeps the organization’s vision and values at the forefront of decision making and action
• Performs other duties as required to support the company's overall strategy and goals

Qualifications

Preferred Qualifications

• Minimum education: BS or MS in Mechanical Engineering or related engineering or scientific discipline, or equivalent work experience
• Minimum of 8 years of relevant experience, minimum 6 years with a masters
• Minimum years’ experience, at least 5 years in medical device manufacturing
• Demonstrated ability to work in cross-functional teams with an ability to leverage internal and external resources to complete tasks
• Experience with validation/verification/qualification of processes, equipment, fixture, tooling, and products
• Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design (FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971, and other related external standards).
• Experience with 60601 and related electrical safety and EMC standards are a strong plus
• Knowledge of component manufacturing processes, tools, and equipment specific to catheter and/or instrument development; electromechanical experience desirable
• Quantitative process development skills including (p)FMEA, Tolerance Analysis, DoE, SPC, GR&R, Hypothesis Testing, and Capability Analyses
• Familiarity with mechanical CAD (Solidworks), ERP (SAP), PLM (Agile), and ALM (Polarion) software
• Strong organizational skills and proven ability to work on multiple fast-paced project threads simultaneously
• Clear and efficient documentation skills

Commitment: 

• Must be available to work full-time and commute/relocate to Sunnyvale, CA
• Up to 10% travel. Some international travel may be required.
• Primary Location: Sunnyvale, CA

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.