Senior Manufacturing Process Engineer — Medical Devices

SGS Consulting; New York (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

SGS Consulting is seeking a qualified Manufacturing Engineer to join our team in the United States. The role focuses on remediation of operations and packaging gaps for EU MDR technical files from an engineering perspective.

You will apply process engineering and project management to support remediation projects, develop manufacturing processes, ECOs, and drawings, and ensure compliance with US FDA and ISO requirements while driving process improvements and CAPA actions.

Qualifications

• 3+ years of experience in manufacturing engineering within the medical device industry.
• Experience with QSR, Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines are required.
• Experience with Statistical Process Control tools required (SPC, Minitab, other software).
• General chemistry, processing, and material expertise.
• Excellent problem-solving, organizational and communication skills.

Responsibilities

• Assist in the remediation of identified gaps related to operations and packaging for EU MDR technical files from an engineering perspective.
• Process engineering and project management to support remediation projects.
• Complete projects to evaluate, analyze, and improve existing processes, support development of new manufacturing processes, and troubleshoot manufacturing processes.
• Ensure that all documentation, drawings, and specifications are generated in compliance with Client's procedures and statutory requirements (US FDA and ISO).
• Coordinate specific efforts as required by the project team.
• Develop manufacturing process requirements, specifications, validations, ECOs and Engineering Drawings.
• Support projects to implement statistical process control (as necessary), analyze and trend process parameters, improve yields, reduce scrap, and error-proof processes.
• Conduct non-conformance investigations, assist or lead CAPA activities.
• Participate in technical teams across Engineering, Manufacturing, Product Development, QA, and Regulatory Affairs.

Job description

SGS Consulting is seeking a qualified Manufacturing Engineer to join our team in the United States. The role focuses on remediation of operations and packaging gaps for EU MDR technical files from an engineering perspective.

You will apply process engineering and project management to support remediation projects, develop manufacturing processes, ECOs, and drawings, and ensure compliance with US FDA and ISO requirements while driving process improvements and CAPA actions.