Bachelor's degree in electrical engineering or related field
Minimum of 4 years direct experience in the medical device industry
Experience with building patient telemetry systems (remote monitoring, vital signs, RF technology)
Strong electrical and/or systems engineering design documentation experience
Good understanding of 21CFR820 regulation, ISO 13485, 14971, and other harmonized standards
Advanced computer skills including Office 365 and Minitab
Experience with medical devices from concept to commercialization
Responsibilities
Support client integration of newly acquired products
Provide input to project goals and recommend revisions
Communicate progress, risks, and trade-offs to project leadership
Complete complex assignments requiring new techniques and procedures
Conduct engineering work in electrical design remediation and product refinement
Assess feasibility of alternative engineering processes and products
Contribute to design hazard analysis and ensure compliance with standards
Benefits
Collaborative work environment with external partners
Opportunities for professional development and skill enhancement
Engagement in innovative medical device projects
Focus on efficient integration of technologies
Supportive team culture that values problem-solving and creativity
Full Job Description
Description
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 plan, 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.
