Job Description

Job Summary

Responsible for leading design validation activities as part of product development initiatives across a wide variety of product categories. This role involves planning, executing, and reporting on design validation efforts. Collaborate with multiple product divisions and cross-functional teams to develop user needs and product requirements, determine appropriate validation methods, and create comprehensive validation plans. Execute simulated use studies and issue study reports. Coordinate the completion of other validation activities and document results to ensure user needs and intended uses have been fully validated. Mentor engineers and provide guidance on design controls and validation practices.

Job Description

Responsibilities:

• Lead design validation activity planning, execution, and completion of documentation.

• Collaborate with design and development teams to develop user needs, product requirements, and risk assessments based on marketing requirements, regulatory strategy, and applicable standards.

• Determine Design Validation method(s) for each user need and intended use to create Design Validation Plan.

• Collaborate with cross-functional groups to develop methods for and ensure completion of all Design Validation deliverables. Track deliverable completion.

• Provide technical expertise by understanding device design to inform test method development, data interpretation, and evaluation of product performance to validate user needs and design inputs.

• Ensure product designs meet all user needs and intended uses.

• Mentor engineers, lead small project teams, and ensure metrics/timelines are met. Provide guidance to other engineers on design controls and design validation practices and procedures.

• Participate in Design Change impact assessments and update Design Validation documentation and deliverables accordingly.

Qualifications:

• Bachelor’s Degree in Engineering or equivalent knowledge.

• At least 4 years with verification or validation testing.

• Experience analyzing and reporting data in order to identify issues, trends, or exceptions.

• Experience evaluating information to determine compliance with standards, laws, and regulations.

• This role requires up to 10% travel.

Preferred Qualifications:

• 7 years of medical device design validation experience would be preferred.

• Experience executing design validation simulated use studies with participants.

• Experience with medical device requirements (Class I-II), design controls, risk assessments, regulatory standards, and root cause analysis.

• Experience with ensuring compliance to CFR 820.30 Design Controls and ISO 14971 Risk Management.

• Experience with compliance interacting with regulatory auditors.

• 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:

$85,280.00 - $123,760.00 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 a more comprehensive list of our benefits please click . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page .

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Medline Industries - Transportation & Operations

Job Tags

Minimum wage, Worldwide,

Similar Jobs