Senior Medical Device Electrical Engineer- R&D & Compliance

Enhanced Compliance Inc.; Marlborough (MA); On-site; USD 100,000 - 160,000; Full time

Job summary

Enhanced Compliance Inc. is seeking an R&D Senior Electrical Engineer in the United States to contribute to product design, development, test method validation, and design history file deliverables for medical devices.

You will support integration of acquired products, communicate progress to leadership, and collaborate with external partners. Strong background in electrical engineering, regulatory compliance, and telemetry systems is required.

Qualifications

• Bachelor’s degree in electrical engineering or related field.
• 4+ years of direct medical device experience.
• Experience with patient telemetry systems (remote monitoring, vital signs, RF technology).
• Strong electrical/design documentation, problem-solving, and attention to detail.
• Familiar with 21 CFR 820, ISO 13485, 14971 and harmonized standards.

Responsibilities

• Support integration of recently acquired products.
• Provide input to project goals and revisions.
• Communicate progress, risks, and trade-offs of technical deliverables to leadership.
• Develop new techniques and procedures for efficient device integration.
• Complete electrical design remediation, product refinement, and test method validation.
• Assess feasibility of alternative engineering processes or equipment.
• Contribute to design hazard analysis and risk management.
• Create clear engineering documentation for knowledge transfer.

Skills

Electrical engineering

Medical device experience

Problem solving

Documentation

Regulatory knowledge

Education

Bachelor's degree in electrical engineering

Tools

SolidWorks

Minitab

CAD software

Office 365

Visio

Job description

Enhanced Compliance Inc. is seeking an R&D Senior Electrical Engineer in the United States to contribute to product design, development, test method validation, and design history file deliverables for medical devices.

You will support integration of acquired products, communicate progress to leadership, and collaborate with external partners. Strong background in electrical engineering, regulatory compliance, and telemetry systems is required.