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Senior Engineer

Irvine, CA 92614

Posted: 04/19/2024 Employment Type: Contract Job Category: Engineering Job Number: 604090 Is job remote?: No Country: United States

Job Description


Target PR Range: 50-60/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:
  • Bachelor's 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Irvine, CA

Take the next step in your career journey in the vibrant city of Irvine, California! Nestled in the heart of Orange County, this thriving community offers unparalleled growth opportunities and an unbeatable quality of life. With its close proximity to stunning beaches, world-class shopping at South Coast Plaza, a bustling culinary scene featuring diverse cuisine options, and cultural attractions like the Irvine Museum and Irvine Barclay Theatre, Irvine has something for everyone. Whether you're into outdoor activities in Irvine Regional Park or catching a game at the Angel Stadium of Anaheim or the Honda Center, this region has it all. Explore our job listings today and discover why Irvine is the perfect place to advance your career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.