Principal Engineer - Molding

Medline; City of Glens Falls (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Medline is seeking an experienced Principal Engineer to lead engineering efforts in product development and molded components for medical devices. You will partner with cross-functional teams to drive verification, validation, and manufacturing excellence in a regulated environment.

The role emphasizes leadership in test method development, risk assessment, and regulatory submissions, with travel up to 10% for business purposes.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Materials, Polymer Engineering or related field.
• At least 7 years in product development and verification/validation testing for polymers, molded components, medical devices, or manufacturing processes.
• Experience with good documentation and laboratory practices.

Responsibilities

• Provide technical leadership to multi-disciplinary teams to develop and execute verification and validation protocols for molded components and complex systems.
• Issue reports for regulatory audits, submissions, and requests.
• Manage multiple testing priorities to meet deadlines and product goals.
• Create documentation recording steps and measurements across the V&V lifecycle.
• Analyze test results and perform root cause analysis to support design changes and risk assessments.
• Lead test method development, fixture design, and validation activities for molded products and manufacturing processes.
• Collaborate with design teams to translate user needs, regulatory strategy, and standards into products meeting requirements and enabling launches.
• Drive process improvements, CAPA support, regulatory investigations, and data trend analyses within the lab and molding operations.

Skills

Technical leadership

V&V protocols

Regulatory audits

Molding processes

Data analysis

Documentation

Cross-functional teams

Root cause analysis

Risk assessment

Education

Bachelors in engineering

Tools

Test equipment

Analytical software

Job description

Job Summary

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.

Job Description

MAJOR 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.

MINIMUM JOB REQUIREMENTS:

Education:

Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Polymer Engineering, or another engineering-related field, or equivalent knowledge and experience.

Work 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.

Knowledge / Skills / Abilities:

Must possess superior organizational, analytical, and problem-solving skills.

Experience with good documentation and laboratory practices.

Additional

Willing to travel up to 10% of the time for business purposes (domestic and international).

PREFERRED JOB REQUIREMENTS:

• 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.