Sr. Manufacturing Engineer (Electrical)
Samsung Healthcare USA · Danvers, MA · 1 wk ago
On-siteEngineeringFull-time
Responsibilities
- Provide engineering, manufacturing, and electrical support for our mobile Computed Tomography (mCT) machines ensuring optimal operation, performance, and adherence to policy.
- Manage changing priorities and respond quickly to challenges in a fast-paced, high-mix, dynamic manufacturing environment.
- Design, develop, and improve manufacturing processes, procedures, and production layouts for product assembly, equipment installation, and material handling.
- Work closely with R&D, Quality, Field Service, and other cross-functional teams to drive the integration of new technologies, process changes, and continuous improvements.
- Validate new components, systems, and process changes to ensure product performance, quality, and efficiency.
- Inspect performance of machinery, equipment, and tools to verify their efficiency. Investigate and initiate corrective action of problems and deficiencies to ensure product quality.
- Adapt machine or equipment design to factory and production conditions.
- Participate and drive MRB investigations with Quality including PCB troubleshooting requiring custom in-house tests.
- Ensure all manufacturing processes, equipment, and procedures comply with industry regulations and standards, with a focus on maintaining safety and product integrity.
- Mentor and coach junior engineers and team members, providing guidance in design, troubleshooting, and process optimization.
- Lead and drive key metrics such as rolled throughput yields, NMR aging status, ECOs, on-time performance, and many more.
- Support Quality during audits with external regulatory bodies.
- Lead and drive investigations on critical components such as PCBs, cables, x-ray tubes that impact manufacturing.
Qualifications and Requirements
- Bachelor’s Degree in Engineering required, Master’s or PhD preferred.
- Minimum of 5 years of relevant electrical engineering experience in capital medical equipment manufacturing.
- Proven ability to lead and execute projects in manufacturing.
- Strong knowledge of medical device regulatory requirements such as 510k submissions.
- Experience in validations and verifications.
- Skilled in understanding PCB troubleshooting and understanding schematics.
- Computer & Analytic Skills: Must be able to analyze and solve drafting problems, assemble facts from various areas, analyze data, and provide informed recommendations. Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environment.