Senior Engineer

(This is an 18-month contract with potential to extend/convert)
Target Pay Range: $52-58/hr
Depending on experience
Summary
Opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. This position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and 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, 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
Highly organized and detail oriented.
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 NCRs and SCARs
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
Bachelors degree (Engineering or Science) is required with 4 years of experience required or Masters Degree (Engineering or Science) and 3 years of related experience required

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