The Principal Manufacturing Engineer is responsible for designing, developing, testing, validating, and implementing processes, tooling, and fixtures for products that are developed by or in collaboration with the R&D group. The Manufacturing Engineer will work closely with development team and serve as a core member of the team through successful transfer into the company’s manufacturing operations.
Essential Duties and Responsibilities:
· Work collaboratively with R&D, Quality and outsourced manufacturer 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 make recommendations for 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 and Quality Engineers
· 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).
· Comply with Presidio Medical’s quality system requirements as well as any applicable regulatory requirements.
· Comply with all health and safety regulations, policies, and work practices.
· Other duties as assigned.
· Bachelor’s degree in Manufacturing Engineering
· Minimum of 15 years of experience in medical device manufacturing with BS
· 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.
· Varied sitting, standing, and walking.
· Ability to lift and carry 50lbs. or less.