Principal Engineer - Automation & Assembly

Medline • Glens Falls, NY

1d

About The Position

The Principal Engineer supports automation and assembly within Medline’s medical device business as a hands-on individual contributor. The role partners with cross-functional teams to design, commission, validate, and improve automated assembly equipment and manufacturing processes. It provides senior technical direction for capital equipment initiatives, equipment and process validation, new machine and process introductions, and continuous improvement in a regulated environment. The position also mentors earlier-career engineers and strengthens long-term automation capability.

The Principal Engineer leads complex automation and assembly projects from concept and machine design through supplier selection, build, factory acceptance testing, installation, commissioning, start-up, validation, production release, and performance optimization. The role develops project scope, requirements, specifications, budgets, schedules, risk assessments, and implementation plans, and manages multiple priorities to meet timelines, cost targets, and business goals.

The position authors, reviews, and executes equipment and process validation documentation and leads equipment qualification and process validation, including IQ, OQ, and PQ. It applies hands-on engineering expertise to troubleshoot complex equipment, process, controls, quality, safety, and performance issues; leads root-cause analysis; and implements corrective actions. The engineer works with Quality, Operations, Maintenance, R&D, suppliers, system integrators, and machine builders to deliver robust, maintainable, production-ready solutions that meet user needs, product requirements, design inputs, safety expectations, applicable standards, and production goals.

The role also leads process improvement, CAPA support, equipment reliability, cycle-time and scrap reduction, capacity expansion, and data-trending initiatives. It evaluates existing equipment and processes and recommends upgrades, redesigns, new technology, or replacement. The engineer provides guidance on PLCs, controls, sensors, robotics, motion control, machine vision, HMIs, data acquisition, and equipment integration, and directs programming and controls work as appropriate. Travel of up to 10% is required for business purposes, including supplier visits, equipment acceptance, and domestic or international project support.

Requirements

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Automation Engineering, Manufacturing Engineering, Mechatronics, Biomedical Engineering, or another engineering-related field, or equivalent knowledge and experience.
• At least 7 years of engineering experience supporting automation, automated manufacturing equipment, assembly systems, machine design, equipment implementation, or manufacturing/process engineering.
• Demonstrated experience commissioning, proving out, validating, and bringing complex automated equipment or manufacturing processes into production.
• Experience providing technical leadership, mentoring engineers, or leading cross-functional engineering projects.
• Strong hands-on knowledge of automated equipment, machine systems, manufacturing processes, and structured technical problem solving.
• Ability to manage capital projects, equipment suppliers, technical requirements, schedules, risks, and multiple priorities.
• Working knowledge of equipment and process validation, technical documentation, change control, root-cause analysis, and process improvement methods.
• Excellent organizational, analytical, communication, collaboration, and problem-solving skills.
• Ability to influence cross-functional teams with a humble, collaborative, and practical leadership style.
• Willingness to travel up to 10% for business purposes.

Nice To Haves

• 10 or more years of direct automation-related experience in a manufacturing environment.
• Experience with medical devices, healthcare products, pharmaceuticals, or another regulated manufacturing environment.
• Experience with Class I or Class II medical devices, design controls, risk management, CAPA, change control, and regulatory or quality-system requirements.
• Hands-on knowledge of PLC programming and industrial controls, including Allen-Bradley platforms.
• Experience with robotics, machine vision, servo or motion control, sensors, HMIs, safety systems, data acquisition, and manufacturing equipment integration.
• Extensive experience taking automated equipment from design and commissioning through validation, production launch, and sustained operation.
• Experience leading capital expenditure projects and working with machine builders, systems integrators, and equipment suppliers.
• Experience developing or validating new machines, assembly processes, manufacturing methods, and products.
• Experience using Lean, Six Sigma, Design of Experiments, process characterization, statistical analysis, or software such as Minitab to improve manufacturing performance.
• Formal leadership experience or demonstrated success mentoring, teaching, and developing less-experienced engineers and technical personnel.

Responsibilities

• Provide technical leadership to multidisciplinary teams working on automation, assembly equipment, manufacturing processes, and complex new product or equipment introductions.
• Lead automated equipment projects from concept and machine design through supplier selection, build, factory acceptance testing, installation, commissioning, start-up, validation, production release, and performance optimization.
• Develop project scopes, technical requirements, equipment specifications, budgets, schedules, risk assessments, and implementation plans; manage priorities to meet timelines, cost targets, and business goals.
• Author, review, and execute equipment and process validation documentation, including protocols, test methods, acceptance criteria, deviations, reports, and traceable technical records.
• Lead equipment qualification and process validation activities, including IQ, OQ, and PQ, for automated assembly systems, manufacturing equipment, fixtures, tooling, software, controls, and supporting processes.
• Troubleshoot complex equipment, process, controls, quality, safety, and performance issues; lead structured root-cause analysis and implement sustainable corrective actions.
• Partner with Quality, Operations, Maintenance, R&D, and suppliers to ensure equipment and processes meet user needs, product requirements, design inputs, safety expectations, applicable standards, and production goals.
• Lead process improvement, CAPA support, equipment reliability, cycle-time and scrap reduction, capacity expansion, and data-trending initiatives in automation and assembly operations.
• Evaluate existing equipment and assembly processes and recommend upgrades, redesigns, controls improvements, new technology, or replacement based on quality trends, downtime, capacity, ergonomics, safety, cost, and business needs.
• Provide technical guidance on PLCs, controls systems, sensors, robotics, motion control, machine vision, HMIs, data acquisition, and equipment integration; direct programming and controls work as appropriate.
• Coordinate internal teams, system integrators, machine builders, component suppliers, and other external partners to deliver robust, maintainable, production-ready solutions.
• Mentor and develop engineers and technical team members, lead small project teams, share automation best practices, and coach on equipment design, commissioning, validation, troubleshooting, and project execution.
• Travel up to 10% for supplier visits, equipment acceptance activities, and domestic or international project support.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance.
• Life insurance.
• Disability insurance.
• 401(k) contributions.
• Paid time off.
• Bonus and/or incentive eligibility.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for employees working less than 30 hours per week.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal