Senior Manufacturing Engineer (Electrical)

• Location: On-site in Danvers, MA

Role Description

The Senior Manufacturing Engineer (Electrical) position will focus on supporting sustaining engineering, production support, projects, and qualifications of 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 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.
• 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. Investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Adapt machine or equipment design to factory and production conditions.
• Participate 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
• Lead and drive investigations on critical components such as PCBs, cables, x-ray tubes that impact manufacturing

Qualifications and Requirements: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 & Experience

• 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.
• Solid experience in leading electrical engineering support
• 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
• Must be able to 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

Competencies

• High attention to detail
• Understanding of terminology and ability to share and communicate effectively within the group
• Ability to organize and prioritize tasks resulting in consistent productivity
• Ability to function within and support a fast-paced team environment and build strong working relationships
• Dependable and punctual
• Ability to meet accuracy and productivity goals
• Good problem solving skills, ability to evaluate situations and prioritize factors in decision making
• Self-motivated, utilize available resources for self-improvement and development
• Flexible: able to follow directives and accomplish tasks outside of normal duties

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!

ests.