Sr Engineer Verification & Validation

Regulatory Toolkit; Mundelein (IL); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in the United States is seeking an experienced Verification and Validation professional to lead regulatory compliance activities, inspecting and testing instrumentation, and documenting evidence trails to ensure procedures and protocols comply with regulatory requirements.

You will develop verification and validation protocols, analyze results, and lead design and failure investigations.

Qualifications

• Bachelor's Degree in Engineering or equivalent knowledge.
• At least 4 years with verification or validation testing.
• Experience analyzing data to identify issues, trends, or exceptions.
• Experience evaluating information to determine compliance with standards, laws, and regulations.

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 on design controls and test lab practices and procedures.

Skills

Data analysis

Regulatory compliance

Education

Bachelor's Degree in Engineering

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.

Job Description

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 on design controls and test lab practices and procedures.

MINIMUM JOB REQUIREMENTS:

Education:

• Bachelor's Degree in Engineering or equivalent knowledge.

Certification / Licensure:

• None

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:

Education:

• None

Certification / Licensure:

• None

Work Experience:

• Experience interacting with regulatory auditors.
• Experience with design controls, risk assessment, and root cause analysis.
• Experience with process improvement and project management.

Knowledge / Skills / Abilities:

• None

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 applicants 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 here.

We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.