What are the responsibilities and job description for the Senior Manufacturing Engineer position at Fusion Life Sciences Technologies LLC?
Job Description: Senior Manufacturing Engineer
Location: Massachusetts, USA
Duration: Initial 4-month contract with an expected extension
Industry: Medical Devices
Job Type: Contract
Job Summary
We are seeking an experienced Senior Manufacturing Engineer to support manufacturing remediation, process validation, and continuous improvement activities for a leading medical device company in Massachusetts. The ideal candidate will have a strong background in medical device manufacturing, process validation (IQ/OQ/PQ), PFMEA, risk management, and quality-driven remediation initiatives.
Key Responsibilities
• Support manufacturing remediation activities to improve process performance and ensure regulatory compliance.
• Develop, execute, and document process validation protocols, including IQ, OQ, and PQ, with a strong focus on Operational Qualification (OQ).
• Develop and update Process Failure Mode and Effects Analysis (PFMEA) and other manufacturing risk assessment documentation.
• Identify process gaps, investigate manufacturing issues, and implement corrective and preventive actions (CAPA).
• Perform root cause analysis and support investigation and remediation activities.
• Drive continuous improvement initiatives to improve manufacturing efficiency, product quality, and process reliability.
• Support engineering change control activities and ensure proper documentation of process changes.
• Collaborate with Manufacturing, Quality, Validation, and other cross-functional teams to ensure compliance with applicable medical device quality and regulatory requirements.
Required Qualifications
• Strong experience in medical device manufacturing engineering.
• Experience with Class II/III medical devices or IVD manufacturing preferred.
• Hands-on experience with process validation (IQ/OQ/PQ), particularly OQ.
• Strong knowledge of PFMEA, risk management, and manufacturing process improvement.
• Experience supporting CAPA investigations, root cause analysis, and remediation activities.
• Experience with engineering change control and technical documentation.
• Strong analytical, troubleshooting, and problem-solving skills.
• Ability to collaborate effectively with cross-functional engineering and quality teams.
Preferred Qualifications
• Experience in regulated medical device manufacturing environments.
• Familiarity with FDA quality system requirements, ISO 13485, and GMP practices.
• Experience supporting manufacturing process improvements and quality remediation projects.