NPI Manufacturing Engineer
NPI Manufacturing Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Primary Scope of Position:
This New Product Introduction Manufacturing-Mechanical Engineer (NPI 3) position reports to the New Product Introduction Engineering Manager for Da Vinci surgical system Instrument products. In this position NPI 3 utilizes their in-depth manufacturing manufacturing equipment technical and design knowledge to collaborate with design engineering to discover define develop and validate new assembly and test equipment and assembly processes solutions. Their primary focus is to develop assembly and test processes establish engineering requirements consider process risks and identify solutions to guide development and ultimately 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 reliability serviceability manufacturability and cost.
Roles and Responsibilities:
Technical Expertise
- In-depth knowledge of equipment and methods to implement assembly and test processes of complex medical devices.
- Strong mechanical engineering skills with proficiency in assembly equipment design is required.
- 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 working with the design team to realize optimal outcomes.
- Provides a voice for the manufacturing process of Intuitives products. Leads product and process DfX (Manufacturing Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
- Proven ability to assess and communicate potential process risks and mitigations to drive appropriate process design.
- 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.
- Supports the creation of an efficient manufacturing assembly line specifying and/or refining BOMs workflows and detailed work instructions. This includes developing and maintaining the process flow and manufacturing process instructions (MPIs) including test procedures.
- 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.
Leadership Requisites
- Supports 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.
- Provides technical support for failure analysis of discrepant production components assemblies and field returns. Leads investigations where appropriate.
- Participates in continuous improvement initiatives focused on material cost reduction capacity enhancement and streamlining of supply chain.
- Provides support and success criteria for responsible projects. Escalate key issues quickly maintaining stakeholder alignment.
- Keep the organizations vision and values at the forefront of decision-making and action
Qualifications :
Skill/Job Requirements:
This role requires active participation to create and refine electro-mechanical components assemblies process documentation tooling and test methods for robotic surgical instruments. The emphasis is on the mechanical design of equipment. The successful candidate will have achieved the following:
- BS Mechanical Biomedical or Manufacturing Engineering with 5 years minimum related experience; MSME MSBMED or MSMfgE with 4 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 strong communication skills to drive assembly equipment fixturing and tooling design from development through implementation
- Strong solid modeling/CAD experience (SolidWorks preferred).
- Familiarity with manufacturing processes including injection molding machining stamping laser welding design of experiments and capability analysis. Experience with automation strongly desired.
- Strong foundation in design fabrication and assembly of complex assemblies with demonstrated knowledge of mechanical assembly techniques test methods including gage R&R analysis DfX and lean principles.
- Strong technical skills in prototyping tooling development process engineering and troubleshooting.
- References who will validate you as a strong a team player self-starter and possessing a can-do attitude!
- Comfortable interacting with engineers management technicians product development planning purchasing regulatory inspection clinical marketing organizations and suppliers.
- Strong problem solving ability including demonstrated ability to effectively design execute report on and draw conclusions from experiments.
- Excellent leadership organization follow-up 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 COVID-19. 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 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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
