Job Summary:

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.

Qualification Requirements:


· 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.

Physical Demands:

· Varied sitting, standing, and walking.

· Ability to lift and carry 50lbs. or less.

This position has been filled.