Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
Participate in design and drawing reviews to ensure that components meet requirements for design and patient safety requirements.
Develop, validate, and improve component inspection strategies and methods to ensure parts meet drawing requirements.
Responsible for defining supplier qualification requirements for components and custom materials, including supplier validations, Edwards receiving inspection test methods and fixture design.
Develop, update, and maintain technical content of part qualification plans and reports.
Investigate complex manufacturing product quality and compliance issues (e.g., NCR, CAPA, SCAR) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, implement corrective actions, and document reports.
Perform other duties and responsibilities as assigned.
Skills
Effective communication and conflict resolution skills, team player
Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
Ability to make sketches, engineering drawings and common computations.
Ability to read and interpret technical drawing, schematics and computer-generated reports.
Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).
Understanding of Risk Management principles
Previous experience with Keyence routine programming
Six Sigma Green or Black Belt/LEAN Manufacturing experience a plus
Ability to manage competing priorities in a fast-paced environment
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Education/Experience
Bachelor's degree (Engineering or Science) is required with 4 years of experience required or Master’s Degree (Engineering or Science) and 3 years of related experience required
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Staffing and Recruiting
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