Senior Manufacturing Engineer

Position: Sr. Manufacturing Engineer
Location: North Haven, CT

Job Summary

We are seeking a Senior Manufacturing Engineer to provide technical leadership and day-to-day manufacturing engineering support across multiple product families within a medical device manufacturing environment. The ideal candidate will have strong experience in manufacturing process development, process validation, root cause analysis, CAPA, and continuous improvement.

This role will partner closely with Production, Quality, Operations, Supplier Quality, and Engineering teams to resolve manufacturing issues, improve product quality and process efficiency, reduce costs, and ensure compliance with applicable quality and regulatory requirements.

Key Responsibilities

• Provide technical leadership and daily manufacturing engineering support for multiple product families.
• Develop, optimize, and improve manufacturing processes to enhance quality, productivity, and cost efficiency.
• Support process validation, manufacturing process development, equipment improvements, and process qualification activities.
• Lead troubleshooting and root cause analysis for manufacturing and product quality issues.
• Support CAPA, corrective actions, deviations, and continuous improvement initiatives.
• Collaborate with Quality and Supplier Quality teams on component qualification, supplier-related issues, and manufacturing investigations.
• Develop and maintain manufacturing documentation, validation protocols/reports, and process-related documentation.
• Apply Lean Manufacturing, Six Sigma, PFMEA, and other continuous improvement methodologies.
• Lead or support cross-functional projects involving manufacturing, quality, engineering, operations, and suppliers.
• Ensure manufacturing processes comply with applicable medical device quality systems and regulatory requirements.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
• 7+ years of manufacturing engineering experience.
• Experience in medical device manufacturing or another highly regulated manufacturing environment.
• Strong knowledge of manufacturing processes, process development, and process validation.
• Hands-on experience with root cause analysis, CAPA/corrective actions, and process improvement.
• Experience working with Quality Systems and regulatory requirements.
• Strong cross-functional communication, problem-solving, and project execution skills.
• Ability to provide technical leadership and support manufacturing operations in an onsite environment.

Preferred Qualifications

• Experience with Lean Manufacturing and Six Sigma.
• Knowledge of PFMEA, risk management, and continuous improvement.
• Experience with equipment/process improvements and cost reduction.
• Experience working with Supplier Quality teams.
• Experience with FDA-regulated manufacturing and ISO 13485.
• Experience supporting multiple product families.
• Validation documentation experience, including protocols and reports.
• Medical device manufacturing experience, particularly within a large regulated manufacturing

Regards
Name: Jyothi Kanwar
Email: jyothi.k@unitedpharmatechnologies.com
Phone Number: 9086284427