Senior NPI Manufacturing Engineer

Primary Scope of Position:

This Senior New Product Introduction Manufacturing Engineer (Senior NPI Engineer) position reports to the Manufacturing Engineering Manager for Da Vinci Single Port Surgical Systems Instrument products. In this position the Senior NPI Engineer utilizes their indepth 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 pokayoke DfX semiautomated 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 nonconformances and performing requalification of production equipment.

Roles and Responsibilities:

Technical Expertise

• Exceptional mechanical engineering skills with demonstrated proficiency in manual assembly techniques. Mechanical design experience is required.
• Indepth 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 Intuitives products. Drives product and process DfX (Manufacturing Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
• Proven 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 recommendations.
• 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.
• Responsible for 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 crossfunctional team to identify root cause establish mitigations and drive implementation using tools such as 8D DMAIC 5Why Fishbones etc..

Leadership Requisites

• Owns new products during pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules resolving manufacturability issues and driving improvements.
• Drives/participates in continuous improvement initiatives focused on material cost reduction capacity enhancement and streamlining continuity of material supply.
• Mentors and sets project tasks for Manufacturing Engineers on their specific project team and on other teams as needed to further company expertise & effectiveness.
• Establish milestones support and success criteria for responsible projects. Drive conclusions and escalate key issues quickly maintaining stakeholder alignment.
• Keep the organizations vision and values at the forefront of decisionmaking and action.

Qualifications :

Skill/Job Requirements:

This role requires effective participation to create and refine electromechanical components mechanical assemblies process documentation tooling and test methods for robotic surgical instruments. The emphasis is on the mechanical design of manufacturing processes and assembly equipment. The successful candidate will have achieved the following:

• BS Mechanical Biomedical or Manufacturing Engineering with 8 years minimum related experience; MSME MSBMED or MSMfgE with 6 years minimum related experience preferred. Related experience is as a design or manufacturing engineer supporting a product with significant mechanical content.
• Demonstrated project leadership and exceptional communication skills to drive assembly equipment fixturing and tooling design from development through implementation.
• Exceptional solid modeling/CAD experience (SolidWorks preferred).
• Demonstrated understanding of manufacturing processes including injection molding machining stamping laser welding design of experiments and capability analysis. Experience with automation highly desired.
• Exceptional foundation in design fabrication and assembly of complex assemblies with demonstrated knowledge of mechanical assembly techniques test methods including gage R&R DfX and lean principles.
• Ability to effectively use statistical methods in data analysis for process development problemsolving statistical process control etc
• Exceptional technical skills in prototyping tooling development process engineering and troubleshooting.
• References who will validate you as an exceptional a team player selfstarter and possessing a cando attitude!
• Comfortable interacting with engineers management technicians product development planning purchasing regulatory inspection clinical marketing organizations and suppliers.
• Exceptional problemsolving ability including demonstrated ability to effectively design execute report on and draw conclusions from experiments.
• Excellent leadership organization followup and documentation skills.

Highly preferred skills & experience:

• Electromechanical new product development experience preferred.
• Experience in an ISO 13485 ISO 9001 or medical device manufacturing environment a plus.
• Experience implementing DfX changes to new or established product preferred.
• Machine tool experience a plus.
• Medical device experience preferred but not required.

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 COVID19. 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.

We provide marketcompetitive 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 COVID19.  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.

Mandatory Notices

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 marketcompetitive 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.

Remote Work :

No

Employment Type :

Fulltime