Senior Medical Device Manufacturing Engineer

SGS Consulting; Williamstown (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

SGS Consulting in New Jersey seeks an experienced manufacturing engineer to support remediation of EU MDR gaps from an engineering standpoint. You will drive process engineering and project management for complex remediation projects in medical devices.

Responsibilities include ensuring documentation complies with US FDA and ISO, coordinating ECOs and drawings, and applying SPC and CAPA methods to improve yields and reduce scrap.

Qualifications

• Bachelor's degree in Engineering required.

Responsibilities

• Assist remediation of gaps in operations and packaging for EU MDR from an engineering view.
• Lead process engineering and project management to support remediation projects.
• Ensure documentation, drawings, and specifications comply with US FDA and ISO.
• Coordinate project team efforts: manufacturing process requirements, specifications, ECOs, drawings.
• Support SPC and process control initiatives to improve yields and reduce scrap.
• Conduct technical investigations and CAPA support under regulatory guidelines.
• Collaborate with Engineering, Manufacturing, Product Development, QA, and Regulatory Affairs.
• Apply problem-solving to identify issues and develop mitigation plans.
• Provide input for manufacturing process development, risk analysis, and design history.
• Suggest equipment changes and upgrade equipment for prototypes and full-scale production.
• Execute other tasks as assigned by management.

Skills

3+ years manufacturing engineering

QSR & Design Controls

SPC/Minitab

Chemistry & Materials

Engineering know-how

Technical writing

Problem solving

Education

Bachelor's degree in Engineering

Job description

SGS Consulting in New Jersey seeks an experienced manufacturing engineer to support remediation of EU MDR gaps from an engineering standpoint. You will drive process engineering and project management for complex remediation projects in medical devices.

Responsibilities include ensuring documentation complies with US FDA and ISO, coordinating ECOs and drawings, and applying SPC and CAPA methods to improve yields and reduce scrap.