Principal Engineer - Molding

Medline•Glens Falls, NY

About The Position

Join our team as a Principal Engineer. We're looking for an experienced engineering leader to support product development and manufacturing operations within our medical device business. In this role, you'll partner with cross-functional teams to lead molding operations, and help 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. In this position you will provide technical leadership to cross-functional product development and manufacturing teams, overseeing verification and validation activities to ensure compliance with regulatory standards. This role evaluates medical devices, molded components, materials, systems, and processes using applicable standards (ASTM, ISO, EN, etc.) and in-house developed methodologies to identify and resolve issues efficiently. The engineer leads process improvement initiatives, supports the advancement of molding operations, documents testing procedures to maintain a clear compliance trail, and develops technical talent to support future product and process needs.

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.
Must possess superior organizational, analytical, and problem-solving skills.
Experience with good documentation and laboratory practices.

Nice To Haves

Experience analyzing and reporting data in order to identify issues, trends, or exceptions.
Experience evaluating information to determine compliance with standards, laws, and regulations.
Experience interacting with regulatory auditors.
Experience with design controls, risk assessment, and root cause analysis.
Experience with process improvement, CAPA activities, project management, and manufacturing or molding operations.
Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
Previous experience in testing and development of medical equipment/devices, molded components, or polymer-based products within the medical device industry.
Have successfully designed and helped launch multiple class II medical devices to market.
Experience with Design of Experiments (DOE), process characterization, and advanced statistical software (Minitab, etc.).
Demonstrated ability to teach and mentor junior engineers, laboratory personnel, or technical team members supporting manufacturing operations.

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 the 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.