Process Engineer

Junior Process Engineer

The Junior Process Engineer supports the development, improvement, and maintenance of manufacturing processes used to produce medical devices. Working closely with Production, Quality, R&D, and suppliers, this role helps ensure products are manufactured efficiently, meet quality standards, and comply with FDA and ISO requirements. This is an excellent opportunity for an early-career engineer to gain hands-on experience in process development, validation, troubleshooting, and continuous improvement within a regulated manufacturing environment.

Responsibilities

• Assist with the development, implementation, and improvement of manufacturing processes, equipment, tooling, and work instructions.
• Support new product introductions through process development, equipment qualification, and production readiness activities.
• Participate in process validation activities (IQ, OQ, PQ) and maintain validation documentation.
• Create and maintain process documentation, including work instructions, process flows, and risk assessments.
• Support manufacturing troubleshooting efforts, root cause investigations, and corrective actions.
• Collaborate with Production, Quality, Engineering, and suppliers to improve process performance and product quality.
• Assist with equipment installations, production transfers, facility layout changes, and process improvement projects.
• Help ensure compliance with FDA regulations, ISO standards, and internal quality system requirements.
• Collect and analyze process data to identify opportunities for efficiency, quality, and cost improvements.
• Participate in Lean and continuous improvement initiatives across the manufacturing operation.

Essential Skills

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or a related engineering discipline.
• 0–3 years of engineering experience in a manufacturing environment; internships and co-op experience will be considered.
• Basic understanding of manufacturing processes, process improvement, and engineering principles.
• Exposure to regulated industries such as medical devices, pharmaceuticals, or other manufacturing environments preferred.
• Familiarity with FDA regulations, ISO standards, process validation, or quality systems is a plus.
• Experience with Microsoft Office applications; ERP systems (D365, SAP, etc.) preferred.
• Exposure to CAD software such as Solid Works is preferred.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to work collaboratively in a fast-paced, team-oriented environment while managing multiple priorities.

Additional Skills & Qualifications

• B.S. in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or another appropriate engineering discipline.
• Experience in the medical device or pharmaceutical industry with direct exposure to regulated manufacturing environments.
• Experience with Lean and Six Sigma methodologies for continuous improvement initiatives.
• D365 or similar ERP system experience preferred.
• Experience in 3D modeling and drafting;
  Solid Works software experience preferred.
• Packaging engineering experience is highly preferred, particularly in medical device applications.
• Experience supporting production transfers, facility layouts, and equipment installations.
• Ability to work effectively in a collaborative, high-urgency environment and align with a culture that values teamwork, accountability, and continuous improvement.
• Strong organizational skills with the ability to maintain comprehensive and compliant documentation.

Work Environment

The role is based in a clean, brand-new manufacturing facility with a strong focus on assembly operations for medical devices. Team members work with a clear sense of urgency to meet quality and delivery expectations while maintaining compliance with FDA and ISO standards. The environment is highly collaborative, with close interaction between Production, Quality, R&D, and Engineering teams. Modern tools and systems, including Microsoft Office and D365 (where used), support daily activities.

The culture emphasizes continuous improvement, safety, and…