Senior Manufacturing Process Engineer

The Manufacturing Engineer leads sustaining engineering and process-improvement initiatives within a highly regulated manufacturing environment. This role supports established product lines, works directly with internal and external stakeholders, drives continuous improvement efforts, and contributes to developing foundational lean practices as the organization scales.

• Provide manufacturing engineering support for assigned product lines in a regulated environment.
• Act as a technical liaison for customers, addressing engineering questions and compliance expectations.
• Lead continuous improvement initiatives such as value stream mapping, waste reduction, workflow optimization, and documentation improvements.
• Own corrective actions from root-cause analysis through validated solutions with measurable results.
• Collaborate closely with engineering, molding, operations, and quality teams.
• Mentor junior engineers and support development of engineering best practices.
• Present technical updates and project outcomes during engineering team meetings.
• Independently manage project schedules, priorities, and deliverables.

• 1+ years of manufacturing engineering experience within a highly regulated industry (required).
• Bachelor's Degree in Engineering required
• Working knowledge of 21 CFR 820 and ISO 13485 or comparable regulatory frameworks (required).
• Demonstrated success leading continuous improvement initiatives with quantifiable results.
• Strong communication skills, including experience interacting with customers or external partners.
• Ability to read engineering drawings; CAD not required.
• Proficient with Microsoft Office and Microsoft Projects.
• Self-driven, proactive, and able to work independently.