Manufacturing Engineer - Medical device

Job Title: Manufacturing Engineer – Medical Devices

Location: Marlborough, MA, or Newark, DE

Duration: 06 Months Extend up to 24 Months

Industry: Medical Devices

Job Summary

We are seeking a Manufacturing Engineer with experience in the medical device industry to support manufacturing operations, process development, validation activities, and continuous improvement initiatives. The ideal candidate will have expertise in regulated manufacturing environments, process optimization, equipment qualification, and compliance with FDA and ISO standards.

Key Responsibilities

• Develop, implement, and improve manufacturing processes for medical device production.
• Support new product introduction (NPI) and transfer from R&D to manufacturing.
• Create and maintain manufacturing work instructions, SOPs, and process documentation.
• Lead process validation activities including IQ, OQ, and PQ protocols.
• Perform root cause analysis and implement corrective and preventive actions (CAPA).
• Collaborate with Quality, R&D, Supply Chain, and Production teams to resolve manufacturing issues.
• Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
• Support equipment selection, installation, qualification, and maintenance activities.
• Ensure compliance with FDA regulations, ISO 13485, GMP, and other applicable quality standards.
• Analyze production data and identify opportunities to improve efficiency, yield, and product quality.
• Participate in risk assessments, FMEA, and design transfer activities.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or related field.
• 3+ years of manufacturing engineering experience within the medical device industry.
• Experience with process validation (IQ/OQ/PQ), GMP, FDA regulations, and ISO 13485.
• Knowledge of CAPA, NCR, root cause analysis, and risk management.
• Experience supporting cleanroom manufacturing environments.
• Proficiency with CAD software (SolidWorks, AutoCAD, Creo, etc.).
• Strong understanding of Lean Manufacturing and continuous improvement methodologies.
• Excellent problem-solving, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Experience with Class II or Class III medical devices.
• Six Sigma Green Belt or Black Belt certification.
• Experience with automated manufacturing equipment and tooling.
• Knowledge of statistical analysis tools such as Minitab.
• Familiarity with ERP systems such as SAP or Oracle.