Sr Engineer Verification & Validation
About The Position
Under limited supervision, the Senior Engineer leads verification and validation activities to ensure regulatory compliance. The role involves inspecting, measuring, analyzing, auditing, calibrating, and testing instrumentation, equipment, software and hardware, machines, and procedures; identifying problems and their sources; and correcting them efficiently. The engineer also implements process improvements and identifies product improvement opportunities. The position develops and executes verification and validation protocols, creates thorough documentation throughout the testing lifecycle, and prepares reports for regulatory audits, submissions, and requests. It analyzes test results and supports design and failure investigations, including root-cause analysis and risk assessment. The engineer leads test-method development, provides technical expertise on device design and core technologies, collaborates with design and development teams, and leads laboratory process improvement and regulatory investigation activities. The role also mentors junior engineers and leads small project teams.
Requirements
- Bachelor’s degree in Engineering or equivalent knowledge.
- At least 4 years of experience with verification or validation testing.
- Experience analyzing and reporting data to identify issues, trends, or exceptions.
- Experience evaluating information to determine compliance with standards, laws, and regulations.
Nice To Haves
- Experience interacting with regulatory auditors.
- Experience with design controls, risk assessment, and root-cause analysis.
- Experience with process improvement and project management.
Responsibilities
- Develop, author, and execute verification and validation protocols, and issue reports for regulatory audits, submissions, and requests.
- Document all steps and measurements throughout the verification and validation lifecycle accurately and thoroughly.
- Analyze test results and contribute to design and failure investigations.
- Determine root causes of defects, safety risks, and performance problems; assess risks and mitigating factors; and check adherence to regulatory standards.
- Lead test-method development, including test fixture design, equipment acquisition, and hardware/software validation.
- Apply knowledge of device design and core technologies to test-method development, data interpretation, and evaluation of product performance against requirements and design inputs.
- Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.
- Lead laboratory process improvement, regulatory investigations, and data-trending activities.
- Research and recommend new equipment and methods, and perform necessary qualifications.
- Mentor lower-level engineers, lead small project teams, and ensure metrics and timelines are met.
- Guide other engineers on design controls and test-lab practices and procedures.
Benefits
- Health insurance
- Life insurance
- Disability insurance
- 401(k) contributions
- Paid time off
- Continuing education and training
- Bonus and/or incentive eligibility
- Access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp for employees working less than 30 hours per week
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What This Job Offers
Job Type
Full-time
Career Level
Senior
