Job Description

Manufacturing Engineer

Job Description

We are seeking a Manufacturing Engineer to support the industrialization, optimization, and continuous improvement of products and processes in a regulated manufacturing environment. This person will work cross-functionally with Operations, Quality, and Customer Service to drive new product introduction (NPI), process optimization, and cost reduction initiatives. The ideal candidate will bring strong technical problem-solving skills, hands-on manufacturing experience, and the ability to manage multiple projects with minimal supervision.

Day-to-Day

• Partner with Operations, Quality, and Design Engineering to support commercialization, process improvements, and cost reduction initiatives.
• Lead root cause investigations, corrective/preventative actions, and process optimization efforts for internal and external product or process issues.
• Specify, source, and qualify capital equipment to support manufacturing needs.
• Author and maintain technical and process documentation, including IQ/OQ/PQ, control plans, process flows, and PFMEAs.
• Analyze mechanical designs, drawings, and measurement systems to ensure manufacturability and alignment with design intent.
• Integrate DFM/DFA and Design-to-Cost principles during verification and validation activities.
• Conduct labor and process studies, analyze data against standards, and drive yield improvements and cost reductions.
• Collaborate with internal teams and external partners to implement and sustain product and process enhancements.

Requirements / Qualifications

• Bachelor’s degree in Engineering.
• 5+ years of manufacturing engineering experience.
• Proficiency with 2D/3D drawings, Bill of Materials, process flow diagrams, control plans, PFMEAs, and process documentation.
• Strong project management, organizational, and time management skills.
• Hands-on experience with root cause analysis, process optimization, and equipment qualification.
• Excellent communication and interpersonal skills with the ability to collaborate across functions.
• Preferred:
• Single-use consumable or biotech device development experience.
• Process characterization using DOE.
• Statistical Process Control (SPC) experience.

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