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Sr. Engineer (Validation Engineer)

Orange County Metro Area, CA

Posted: 01/22/2019 Job Type: Engineering Job Number: JN -012019-23459
Sr. Engineer (Validation Engineer)
Lifesciences Industry

Irvine, CA

Job Functions / Responsibilities:
  • Support a range of R&D laboratory validation activities including feasibility evaluations, and test equipment, fixtures/tooling, and test method validations.
  • Qualify R&D laboratory test equipment and test methods including writing protocols, coordination of all equipment / test method validation activities, data analysis using statistical techniques and authoring reports.
  • Develop equipment installation qualification (IQ), software validation (SWV), and test method validation (TMV) protocols / reports in compliance with company procedures.
  • May develop or revise test methods and test strategy.
  • Submit ECRs (Engineering Change Request) to create or revise validation documentation, test methods, and fixture drawings
  • Identify opportunities for design/re-design of basic test equipment, tools, fixtures, etc. to improve existing test methods and lab processes
  • Maintains compliance with applicable GMP standards, ISO Standards, local Standard Operating Procedures (SOP)'s and company policies. Maintain a safe work environment for self and other employees.
Required Skills, Experience and Education:
  • Bachelor's Degree in Engineering, preferably Mechanical, Biomedical, Chemical or Electrical Engineering. Master's Degree or equivalent in Engineering preferred.
  • Minimum four years experience in medical device or similar regulated industry. Experience in medical device development, material testing and evaluation, and/or process development, particularly equipment validation and test method validation preferred.
Skills/Experience to include the following:
  • Experience in developing and executing equipment and fixture installation qualification (IQ), software validation (SWV), and test method validation (TMV) protocols/reports in an FDA regulated environment.
  • Must be able to effectively articulate, verbally and in writing, results and conclusions to technical and non-technical personnel. Must have strong technical writing skills.
  • Ability to work well both independently and as a member of a cross-functional team in a dynamic environment is essential.
  • Strong problem-solving, organizational, analytical and critical thinking
  • Excellent teamwork and interpersonal skills including negotiating and relationship management
  • Must be a highly motivated self-starter who is driven to achieve quality and value-add results with appropriate direction. Candidate must seek direction when appropriate.
  • Working knowledge and understanding of statistical techniques required
  • Proven expertise in Microsoft Office Suite and Minitab
  • Clear understanding of good documentation practices and medical device quality system regulations and requirements
  • Experience in medical device testing and/or process development preferred. Prior experience working in a lab environment with flow, pressure, leak, tensile, thermal and other test instrumentation is highly desirable
  • Fixture design experience desirable. CAD (Solidworks or Pro/E) experience a plus
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