Senior Electrical Engineer - Medical Device #1377

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

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role

Enhanced Compliance (ECI) is searching for an R&D Senior Electrical Engineer candidate who will contribute and assist ECI client project teams with the following activities: product design and development, test method development and validation and other deliverables within the design history file.

What You’ll Do

• Support our client in the integration of recently acquired products.
• Providing input to project goals and progress and recommending appropriate revisions.
• Effectively communicate progress, risks, and trade-offs of technical deliverables to project leadership, and recommends revisions as needed.
• Complete complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the product portfolio.
• Successfully complete engineering work in electrical design remediation, product design refinement, preparation of specifications, test method validation, and report preparation.
• Assess the feasibility and soundness of alternative engineering processes, products, or equipment.
• Contribute to design hazard analysis, FMEA, and ensuring compliance with our client’s design control and risk management standard operating procedures.
• Complete clear and concise engineering documentation to facilitate knowledge transfer during product integration.
• Collaborate with external partners and suppliers to align component specifications, qualification and acceptance activities, testing protocols, and quality standards.

What We Look For

• Bachelor’s degree in electrical engineering or related field
• Minimum of 4 years direct experience in medical device industry, preferred.
• Experience with building patient telemetry systems (remote monitoring, vital signs, RF technology)
• Strong electrical and/or systems engineering design documentation experience, problem-solving skills and attention to detail
• Experience with durable medical capital equipment in addition to single-use-devices is preferred .
• Strong engineering, design, and analysis skills.
• Experience with medical devices from concept to commercialization.
• Must have a good understanding of 21CFR820 regulation, ISO 13485, 14971, and other harmonized standards.
• Advanced computer skills including Office 365 applications (Word/Excel/PowerPoint/project/Visio, Teams, etc.), and Minitab statistical analysis software is required. SolidWorks or equivalent CAD systems experience preferred. Experience with electronic data management system is plus.
• Proven ability to pan, organize and prioritize own daily work routine; strong focus on achievement is consistent, brings innovative solutions and supports cost-effective delivery.
• Consistently accomplishes goals and objectives within established timeframes.
• Adept at identifying creative and efficient solutions to engineering challenges, translating customer requirements into workable product ideas and solutions.
• Good analytical and problem-solving skills.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from now or in the future .