Senior Manufacturing Engineer

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Intuitive in Sunnyvale, CA is seeking a Manufacturing Engineer to establish and optimize manufacturing processes for new product development accessories and support ongoing operations of robotic surgical instrument components. You will design fixtures, qualify equipment, perform PFMEA, IQ/OQ/DQ/PQ, and guide DFx initiatives to improve yield, reliability, and cost.

A strong background in medical device manufacturing is required and you will collaborate with cross-functional teams to drive

Qualifications

• Experience creating and validating manufacturing processes for medical device accessories.
• Familiarity with risk assessment and qualification protocols.
• Ability to lead cross-functional teams on product launches.

Responsibilities

• Develop manufacturing assembly processes and test methods for new product development accessories.
• Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
• Analyze instrument/accessories manufacturing line from a risk perspective (PFMEA) to validate critical tests used in manufacturing.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging IQ/OQ/DQ/PQ.
• Create, maintain and improve pilot “mid to high volume” manufacturing assembly lines, BOMs and work instructions.
• Provide production support through successful and sustained project launch.
• Identify and implement continuous improvement projects for yield, cycle time, reliability and cost.
• Provide DFx input to enhance manufacturability of new products and maintain regulatory compliance.
• Takes responsibility for maintaining compliance with medical device quality system including CAPA and ECO implementation.

Skills

Manufacturing process development

PFMEA

IQ/OQ/DQ/PQ

Fixture/tooling design

BOM & manufacturing planning

DFx (design for manufacturability)

Job description

Job Description

Primary Function of Position

Individuals in this role will establish and develop manufacturing processes for new product development accessories, as well as provide daily support for manufacturing operations and mechanical design improvements for existing accessories. The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling, manufacturing equipment, and test methods while challenging new product designs to improve efficacy, reliability, manufacturability and cost for robotic surgical instruments and accessories.

Essential Job Duties

• Develop manufacturing assembly processes and test methods for new product development accessories.
• Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
• Analyze instrument/accessories manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
• Create, maintain and improve pilot “mid to high volume” manufacturing assembly lines, specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions.
• Provide production support through successful and sustained project launch.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
• Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.
• Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
• Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.