Sr. Engineer (Validation Engineer)
Orange County Metro Area, 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.
- 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.
- 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