Principal Engineer - Automation & Assembly

Job Summary

Join our team as a Principal Engineer supporting Automation and Assembly. We’re looking for an experienced, hands-on individual contributor to support product development and manufacturing operations within our medical device business. In this role, you’ll partner with cross-functional teams to design, commission, validate, and improve automated assembly equipment and manufacturing processes. This is a high-impact opportunity for someone who enjoys solving complex technical challenges, bringing highly technical equipment from concept through production, mentoring engineers, and advancing manufacturing excellence in a regulated environment.
In this position, you will serve as a senior technical resource for automation and assembly, leading capital equipment initiatives, equipment and process validation, new machine and process introductions, and continuous improvement. You will provide technical direction across engineering, operations, quality, maintenance, and external equipment suppliers while developing earlier-career engineers and strengthening long-term automation capability.

Job Description

MAJOR RESPONSIBILITIES:

· Provide technical leadership to multidisciplinary teams responsible for automation, assembly equipment, manufacturing processes, and new product or equipment introductions of advanced complexity.

· 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 scope, technical requirements, equipment specifications, budgets, schedules, risk assessments, and implementation plans for capital equipment projects. Manage multiple priorities and ensure timelines, cost targets, and business goals are met.

· Author, review, and execute equipment and process validation documentation, including protocols, test methods, acceptance criteria, deviations, reports, and traceable technical records supporting regulatory and quality requirements.

· 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.

· Apply hands-on automation and manufacturing engineering expertise to 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 reduction, scrap reduction, capacity expansion, and data-trending initiatives within 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 related to PLCs, controls systems, sensors, robotics, motion control, machine vision, HMIs, data acquisition, and equipment integration. Direct programming and controls work as appropriate to the project.

· Coordinate internal teams, system integrators, machine builders, component suppliers, and other external partners to deliver robust, maintainable, and production-ready solutions.

· Mentor and technically develop engineers and technical team members. Lead small project teams, share automation best practices, and provide coaching on equipment design, commissioning, validation, troubleshooting, and project execution.

MINIMUM JOB REQUIREMENTS:

Education:

· 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.

Work 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.

Knowledge / Skills / Abilities:

· 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.

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