Principal Engineer - Molding (Medical Devices)

Location: Glens Falls, New York, United States; onsite role. Travel up to 10% domestically and internationally.

Salary: $116,000–$174,000 annually; bonus and/or incentive eligible.

Company

hirify.global develops and manufactures healthcare and medical device products through a growing worldwide organization.

What you will do

• Provide technical leadership to multidisciplinary product development, laboratory, and molding manufacturing teams.
• Develop, author, and execute verification and validation protocols for medical devices, molded components, materials, and systems.
• Analyze test results, investigate failures and defects, assess risks, and verify compliance with ASTM, ISO, EN, and applicable regulatory standards.
• Lead test method development, including fixture design, equipment acquisition, hardware and software validation, and process qualification.
• Drive molding and laboratory process improvements, CAPA support, regulatory investigations, data trending, and equipment or method recommendations.
• Mentor junior engineers and technical staff while leading small project teams and supporting product launches.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Polymer Engineering, or a related engineering field, or equivalent knowledge and experience.
• At least 7 years of experience in product development and verification or validation testing.
• Experience with polymers, molded components, medical devices, or manufacturing processes.
• Strong organizational, analytical, and problem-solving skills, with experience in good documentation and laboratory practices.
• Ability to evaluate compliance with standards, laws, and regulations and interact with regulatory auditors.
• Experience with design controls, risk assessment, root cause analysis, process improvement, CAPA, project management, or molding operations.

Nice to have

• Experience with Class I–II medical devices, the 510(k) process, and launching Class II devices.
• Experience with Design of Experiments, process characterization, and advanced statistical software such as Minitab.
• Experience testing medical equipment, molded components, or polymer-based products in the medical device industry.
• Experience teaching and mentoring engineering, laboratory, or manufacturing personnel.

Culture & Benefits

• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access where applicable.
• Inclusive workplace focused on belonging, diversity, and career growth.