Job Description

Medical Devices - Senior Manufacturing Engineer II (Electrical) $105k - $120k

US Work Eligibility: US Citizen or Green card holders only

We are seeking a Senior Manufacturing Engineer II to enhance the design, manufacturing, and assembly processes and to optimize the production of implantable components, ensuring compliance with design specifications and regulatory standards.

RESPONSIBILITIES:

• Lead design-for-manufacturing (DFM) reviews and optimize processes with key vendors.
• Develop and validate manufacturing processes from prototype to production:
• Select, design, install, and validate equipment.
• Streamline costs and enhance supply chain efficiency.
• Define and ensure product output specifications.
• Plan, coordinate, and execute detailed manufacturing phases:
• Collaborate with technicians and stakeholders.
• Review and maintain 2D/3D CAD designs.
• Apply GD&T analysis per ASME Y14.5 and Y14.100 standards.
• Create work instructions covering process time, capacity, and workflows.
• Oversee design transfer to manufacturing
• Manage schedules, procurement, vendor relations, and manufacturing environments.
• Verify products and processes using statistical controls and ensure traceability.
• Develop test plans to meet design and output specifications.
• Perform failure analysis and implement corrective actions.
• Conduct risk analysis and manage suppliers through production.
• Support regulatory submissions with detailed documentation.

REQUIREMENTS:

• Bachelor’s in Mechanical, Electrical, Biomedical, or Manufacturing Engineering (Master’s preferred).
• 3–5 years of experience in product/process development and manufacturing engineering (medical device industry preferred).
• Strong knowledge of process characterization, pFMEAs, MVP, IQ/OQ/PQ/PPQ, and TMVs.
• Familiarity with ISO 13485, FDA quality systems, and design controls.
• Experience in logistics and supply chain management is a bonus.
• Proficiency with industry best practice and standards.

Do you want the chance to work on life-saving technology in a multidisciplinary, fast-paced environment?

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