Senior Manufacturing Engineer

Medical Devices - Senior Manufacturing Engineer II (Electrical) $105k - $120kUS Work Eligibility: US Citizen or Green card holders onlyWe 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 2D3D 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 manufacturingManage 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 productprocess development and manufacturing engineering (medical device industry preferred).Strong knowledge of process characterization, pFMEAs, MVP, IQOQPQPPQ, 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?

Created: 2025-01-26