Manufacturing Engineer (IQ/OQ/PQ/ISO 13485/CAD/Electro-Mechanical)

The Sr. Manufacturing Engineer, Capital, supports a growing medical robotic business. Make an impact by improving current manufacturing processes, introducing new parts, and working with vendors. You'll support the surgical robot manufacturing line to facilitate efficient operations, optimize existing processes, and ensure that production goals are met. Individuals in this role will provide daily support for manufacturing operations, mechanical design improvements for existing processes and hardware

Key Responsibilities:

• Lead outsourcing efforts at contract manufacturers and process validation activities including IQ/OQ/PQ protocols and reports in ISO 13485 regulated environment.
• The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods while challenging new product designs to improve efficacy, reliability, manufacturability and cost for robotic surgical capital equipment.
• Create, maintain and improve pilot capital equipment manufacturing assembly lines, specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ)
• Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new and existing products
• Develop and set up manufacturing assembly line, release and/or refine bill of materials (BOMs), work flow processes and detailed manufacturing process instructions (MPI) work instructions.
• Conceives and plans complex projects and studies involving process or product costs, process control, or other labor related issues.
• Provides estimates in the development and coordination of a 5 year capital budget.

Qualifications - External

Qualifications

Education:

• Minimum Bachelor's Degree in an Engineering, Biomedical, Physics or related discipline is required

Experience and Skills:

Required:

• experience as design or Manufacturing Engineer supporting product with significant mechanical / electromechanical content
• Computer Aided Design Experience (CAD) is recommended

Preferred:

• Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams
• Prior responsibility for process, equipment or product validation/verification
• Great attitude, eager, willing/able to take initiative, works well with others in team environment

Other:

• This position is 100% On-Site Monday- Friday in Redwood City, CA
• Ability to travel up to 10% domestic and international

Job Type: Contract

Pay: $70.00 - $75.00 per hour

Experience level:

• 6 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Education:

• Bachelor's (Preferred)

Experience:

• Manufacturing engineering: 6 years (Preferred)
• IQ/OQ/PQ protocols and reports: 6 years (Preferred)
• Working in ISO 13485 regulated environment.: 6 years (Preferred)
• Computer Aided Design Experience (CAD): 6 years (Preferred)
• mechanical / electromechanical: 6 years (Preferred)
• pharma or biotech or medical device industry: 6 years (Preferred)

Ability to Commute:

• Redwood City, CA 94062 (Preferred)

Work Location: In person