Job Summary
Job Description
JOB SUMMARY: Under limited supervision, lead verification and validation activities. Ensure regulatory compliance by inspecting, measuring, analyzing, auditing, calibrating and testing instrumentation, equipment, software/hardware, machines and/or procedures. Identify problems and their sources and correct them quickly and efficiently. Implement process improvement initiatives and identify product improvement opportunities. Create and document an evidence trail to show that the procedures and protocols used during testing are accurate and follow regulatory requirements.
MAJOR RESPONSIBILITIES:
- Develop, author, and execute verification and validation protocols. Issue reports for regulatory audits, submissions and requests.
- Create accurate and thorough documentation that records all steps taken and all measurements used through the verification and validation lifecycle.
- Analyze test results and contribute to design and failure investigations. Determine the root cause of defects, safety risks, and performance problems. Use the data to provide a risk assessment, identify mitigating factors and check for adherence to regulatory standards.
- Lead test method development activities including test fixture design, equipment acquisition, and hardware/software validation.
- Provide technical expertise by understanding device design and core technologies to inform test method development, data interpretation, and evaluation of product performance to verify product requirements and design inputs.
- Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.
- Lead process improvement, regulatory investigations, and data trending activities within the laboratory. Research and recommend new equipment/methods and perform necessary qualifications.
- Mentor lower level engineers, lead small project teams and ensure metrics/timelines are met. Provide guidance to other engineers ondesign controls and test lab practices and procedures.
Education
- Bachelor’s Degree in Engineering or equivalent knowledge.
Work Experience
- At least 4 years with verification or validation testing. Knowledge / Skills / Abilities
- Experience analyzing and reporting data in order to identify issues, trends, or exceptions.
- Experience evaluating information to determine compliance with standards, laws, and regulations.
PREFERRED JOB REQUIREMENTS
- Experience interacting with regulatory auditors.
- Experience with design controls, risk assessment, and root cause analysis.
- Experience with process improvement and project management.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$92,000.00 - $138,000.00 Annual
The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click .
