Top 3 required technical skills:

• Project & time management/organization/planning
• Minitab/data analysis
• problem solving

Nice to have skills:

• Inspection development
• Risk management
• Solidworks/Creo
• Six sigma

Job Description: The Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and clients systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Job Responsibilities:

• 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, clients 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 problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
• 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