Santa Clara, CA

Position Overview

The Principal Manufacturing Engineer is responsible for designing, developing, testing, validating, and implementing processes, tooling, and fixtures for products that are developed by the Research and Development (R&D) group. The Manufacturing Engineer will work closely with development teams and serve as a core member of the team through successful transfer into the company’s manufacturing operations.

Essential Job Functions

• Work collaboratively with R&D, Quality and Production departments to design, develop, test, validate and implement processes, tooling, and fixtures.
• Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
• Perform tolerance analyses for components, manufacturing materials, packaging, and supplies used for in-house processing.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
• Participate in development and maintenance of product design FMEAs.
• Identify requirements, advise Operations management, prepare proposals and implement equipment & fixturing needed for development and manufacturing efforts.
• Develop and maintain documentation for design control, product configurations (e.g., bills-of-materials), and other Quality System requirements.
• Lead and/or actively participate in product/process engineering problem resolution.
• Lead and/or actively participate in process/product improvement projects, Validation activities (IQ, OQ and PQ) in cooperation with R&D engineers, Quality and technicians.
• Assist Materials, QA and R&D departments with supplier selection and technical development.
• Conduct complex engineering studies and investigations and prepare reports for company leadership.
• Provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.
• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products).
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Requirements

• Bachelor’s degree in Manufacturing Engineering.
• Minimum of ten (10) years of experience in medical device manufacturing with BS or, six (6) years of experience with MS or PhD degree.
• Experience with process validations (IQ-OQ-PQ), Lean Sigma, 6S.
• Strong in Statistics (process capability, CPK, DOE’s, Normality, Hypothesis Testing).
• Demonstrated proficiency in written and verbal communication, including creating and delivering presentations.
• Advanced skills in critical software applications, such as Microsoft Office and Solidworks.
• Expertise in data and problem analysis, creative problem solving and design thinking.
• Tooling and Equipment design a plus.
• Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements).
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.