Electrical Engineer

Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace, offering proactive, preventative, and corrective solutions that validate processes, ensure compliant quality systems, and close gaps between current and FDA-expected stages. MEC provides short or long-term support, from high-end leaders and consultants to skilled engineering staff and subject-matter experts (SMEs). Our mission is to inspire positive cultural change from within and always exceed client expectations.

About the role

This onsite contract position receives minimal technical direction on a broad scope of new, complex R&D, manufacturing, and test equipment projects. As an independent contributor or team member, you will develop concepts, execute specifications, and design, plan, and build multiple complex internal manufacturing and test equipment projects. You will be viewed as an expert in one or more technologies.

Responsibilities

• Manage an IEC 60601-1 testing project, serving as the main point of contact with the test laboratory, triaging issues to core team members, troubleshooting test issues, and documenting the test plan and report.
• Perform standards-based testing, specifically EMC and safety testing.
• Support different divisions for sustaining fielded products.
• Analyze design changes from individual circuits up to fully configured products.
• Conduct component analysis for BOM replacements, specifying needed testing to support replacements.
• Test new or replacement circuit board-level components, assessing results against test criteria.
• Assess electrical and system compatibility between medical devices.
• Work with internal or contract manufacturing on manufacturing-associated challenges.
• Analyze challenges or failures of circuit boards, cables, power supplies, or displays.
• Perform electrical testing of PCBAs and products, documenting and implementing design updates.
• Work cross-functionally with quality, regulatory, sourcing, and manufacturing departments.
• Support regulatory submissions by answering questions about test results, rationale for design requirements, or standards compliance.
• Ensure compliance with internal Quality System requirements across all engineering documentation.
• Build Quality into all aspects of work by maintaining compliance with quality requirements.

Requirements

• Bachelor's degree or higher in systems or electrical engineering from an accredited institution.
• Minimum of 7 years' experience in electrical engineering, particularly in electrical hardware design and test execution.
• Experience with test equipment such as multimeters, oscilloscopes, signal generators, spectrum analyzers, network analyzers, as well as manual tools like soldering irons and crimpers.

Qualifications

• Background in a regulated industry, preferably with Class II or III medical devices.
• Strong familiarity and experience with IEC 60601-1 and IEC 60601-1-2 testing.
• Strong verbal and written communication skills, with the ability to clearly convey technical concepts.
• Ability to manage tasks independently while collaborating across multidisciplinary teams.
• Ability to work cross-functionally across engineering, quality, regulatory, and manufacturing teams.
• Experience with Altium PCB layout tool.

Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.