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About the Role

Join our team as a Principal Engineer supporting product development and manufacturing operations within our medical device business. You will partner with cross-functional teams to lead molding operations and bring innovative healthcare products to market. This is a high-impact opportunity for someone who enjoys solving complex technical challenges, influencing cross-functional teams, and advancing manufacturing excellence in a regulated environment.

Responsibilities

Provide technical leadership to multi-disciplinary teams to develop, author, and execute verification and validation protocols for new and existing products, molded components, materials, and systems of advanced complexity.
Issue reports for regulatory audits, submissions, and requests.
Manage multiple testing priorities and ensure deadlines and product goals are met.
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 data to provide a risk assessment, identify mitigating factors and check for adherence to regulatory standards.
Lead the planning, development, and execution of test method development activities, including test fixture design, equipment acquisition, hardware/software validation, and methods supporting molded products and manufacturing processes.
Provide technical expertise by understanding device design, polymer and material characteristics, molding processes, and core technologies to inform 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.
Ensure new product designs meet all product requirements and experience a successful launch.
Lead process improvement, CAPA support, regulatory investigations, and data trending activities within the laboratory and molding operation.
Research and recommend new equipment or methods and perform necessary qualifications.
Review existing products, molded components, and manufacturing processes and recommend improvements based on complaints, risk analyses, manufacturing feedback, quality trends, and cost-saving opportunities.
Coordinate product design, laboratory, and molding manufacturing teams across all phases of product and process development to ensure applicable design inputs and process requirements are verified and validated.
Mentor junior engineers and technical team members supporting molding, lead small project teams, and ensure metrics and timelines are met.
Provide guidance on design controls, test laboratory practices, molding-related technical problem solving, and procedures.

Requirements

Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Polymer Engineering, or another engineering-related field, or equivalent knowledge and experience.
At least 7 years of experience in product development and verification or validation testing, including experience supporting polymers, molded components, medical devices, or manufacturing processes.
Superior organizational, analytical, and problem-solving skills.
Experience with good documentation and laboratory practices.
Willing to travel up to 10% of the time for business purposes (domestic and international).

Skills

Design controls
Risk assessment
Root cause analysis
Process improvement
CAPA activities
Project management
Manufacturing operations
Molding operations
Medical device requirements (Class I-II)
510k process
Design of Experiments (DOE)
Process characterization
Advanced statistical software (Minitab, etc.)
Teaching and mentoring junior engineers, laboratory personnel, or technical team members supporting manufacturing operations.

Location

Domestic
International

Work Type

Full-time

Experience Level

Principal Engineer
7+ years of experience

Education Level

Bachelor's Degree

Salary/Compensations

$116,000.00 - $174,000.00 Annual

Benefits

Health insurance
Life and disability
401(k) contributions
Paid time off
Access to the Employee Assistance Program
Employee Resource Groups
Employee Service Corp

About the Company

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
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.

Equal Opportunity

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.