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Senior Manufacturing Engineer (Electrical Engineering, Capital Equipment)

• Location:  On-site in Danvers, MA

Who We Are

Samsung HME America (Healthcare and Medical Equipment) is Samsung’s U.S. medical imaging organization, delivering advanced diagnostic solutions across Ultrasound, Digital Radiography, and Computed Tomography. We lead nationwide sales, marketing, service, and distribution of Samsung’s imaging technologies, partnering with healthcare providers to strengthen diagnostic capabilities, streamline clinical workflows, and support better patient care. Samsung HME America also serves as the global manufacturing center for Samsung’s mobile Computed Tomography (mCT) business, leading the development of advanced CT systems used by healthcare providers worldwide.

Backed by Samsung Electronics’ global technology leadership, our teams work closely with clinicians to translate real-world challenges into innovative imaging solutions. Our culture combines a sense of urgency, customer focus, and clinical collaboration to advance the future of medical imaging.

Role Description

The Senior Manufacturing Engineering – Electrical Engineering position will focus on supporting sustaining engineering, production support, projects, and qualifications of mobile computed tomography (mCT) systems manufactured in Danvers, MA by Samsung HME America.  Responsibilities for this position will include leading product quality issues in manufacturing, component quality issues from incoming inspection, leading sustaining engineering projects, validation execution, NPI and design transfer, root cause investigation with Quality functions, manufacturing job instructions, compilation of engineering and technical reports, coordinating tasks and creating engineering orders. 

The role is considered as an SME/Expert in Electrical Engineering to support manufacturing operations for capital equipment. The role will interact directly with the manufacturing operators, R&D, warehouse team, supplier quality engineers, operations quality engineers, and field service engineers. This role will have key focus towards leading electrical engineering related issues on finished products, issues on critical components such as PCBs, batteries, etc., changes planned on released products due to quality or design gaps. Further, this position will also support any critical system level tests planned with external testing houses such as Intertek which are required in accordance with regulatory requirements.

Key duties and responsibilities, other duties may be assigned:

• 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.
• Program, troubleshoot, and integrate automated wire processing, programmable logic controllers (PLCs), human-machine interfaces, and machine vision systems.
• 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.
• Inspects performance of machinery, equipment, and tools to verify their efficiency. Investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Adapts machine or equipment design to factory and production conditions.
• Participates in and drives 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 (FDA, MDSAP, etc.).
• Lead and drive investigations on critical components such as PCBs, cables, x-ray tubes that impact manufacturing.

Qualifications and Requirements: This position requires an electrical engineering degree and experience in working with capital equipment. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education, Skills & Experience

• Minimum of 5+ years of relevant electrical engineering experience in capital medical equipment manufacturing
• Requires a bachelor’s degree in electrical engineering minimum or higher (Master’s or PhD)
• Experience working in highly regulated spaces (e.g. Aerospace, Automotive/EV, Medical Devices, or Defense)
• Strong experience in capital equipment manufacturing and leading electrical engineering support 
• 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 capital equipment troubleshooting
• Understanding electrical schematics, wire harness routing, panel layouts, and IPC workmanship standards

Computer Skills

• Microsoft Office, ERP systems such as SAP or relevant
• PLM system such as Agile, Arena or similar
• Skilled in electrical schematics, BOMs, drawings, etc.

Competencies

• Electrical Engineering experience and familiarity with complex electromechanical capital systems, PCBs, circuits, and electrical schematics preferred.
• Strong technical aptitude with ability to troubleshoot PCBs, interpret schematics, execute hardware and firmware tests, and offer effective solutions
• Demonstrated experience in validation and verification
• Practical knowledge of project management and a self-starter to lead and drive projects
• Strong attention to detail
• Strong written and verbal communication skills and comfort in presenting to leadership
• Ability to manage changing priorities and maintain productivity in a high-paced, evolving environment. 
• Strong technical and electrical engineering aptitude with ability to offer effective solutions
• Experience with statistical methods is strongly preferred
• Experience in manufacturing and regulated industry is strongly preferred
• Demonstrated leadership skills and ability to foster collaboration and teamwork

Physical Requirements

• Occasionally lift and /or move up to 25 pounds
• Frequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hear
• Must be able to sit for long periods of time 
• The noise level in the work environment is usually mild.
• Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus
• Interaction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full time or as necessitated by situation 

Benefits

We offer a comprehensive benefit package which includes:

• Medical (Blue Benefit Administrators): 5 PPO Plans (with up to 95% employer contribution)
• Dental (Blue Cross Blue Shield): 2 PPO Plans (with up to 80% employer contribution)
• Vision (Blue Cross Blue Shield): 100% company paid
• Short/Long Term Disability, Life & AD&D (The Standard): 100% company paid
• 401k Retirement (Fidelity): 100% company match up to 5%
• Tax Deferred Health Care Savings Programs
• Accident Insurance, Critical Illness, Hospital Indemnity, Pet, Legal, ID Theft 
• Generous paid time off, tuition reimbursement, and more!

Inclusion and Diversity Statement: We are an Equal Opportunity Employer and value diversity at all levels of the organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We are committed to providing reasonable accommodation to individuals with disabilities throughout the application and employment process. If you require assistance or accommodation, please contact Human Resources.

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