Electro-Mechanical R&D Engineer

Now Hiring: Electro-Mechanical R&D Engineer Location: Princeton, NJ (Onsite) Contract Duration: 1 Year

Position Overview:

We are seeking an experienced Electro-Mechanical R&D Engineer to support the development of cutting-edge medical devices in Princeton, NJ. The ideal candidate will have strong experience in mixed-signal circuit design, EMC testing, and product safety compliance. This position requires cross-functional collaboration and adherence to medical device regulatory standards, including those from UL, IEC, and FDA.

Key Responsibilities:

Lead and contribute to electro-mechanical medical device R&D , including feasibility studies, prototyping, and system-level integration.

Design and analyze mixed-signal analog-digital circuits for complex instrument subassemblies.

Develop and implement EMC, Wireless, and Product Safety compliance strategies in collaboration with cross-functional engineering teams.

Prepare and maintain EMC Test Plans and Reports in accordance with IEC/EN 61326-1, 61326-2-6, and related standards.

Set up and manage EMC and Safety test equipment; develop and update equipment SOPs.

Perform and guide UL/CSA/IEC safety testing (61010, 60950, 62368-1), including assessments for design changes.

Troubleshoot and resolve EMC and EUT performance issues during testing.

Conduct software and equipment validations aligned with the Abbott Quality System.

Interface with external certification agencies (UL, CE, CB Scheme) for documentation and testing.

Drive development and execution of verification & validation protocols , test methods, and support CAPA investigations.

Maintain product documentation and support ongoing compliance efforts throughout the product lifecycle.

Travel up to 5% for training or project support as needed.

Required Skills & Tools:

Strong technical expertise in EMC testing, circuit design, and product safety compliance

Familiarity with regulatory standards : IEC 61010, 60950/62368-1, 61326, CE, UL, FDA

Experience with PCB CAD/Layout Tools : ORCAD Capture, Mentor Graphics PADS, PSpice

Working knowledge of EMC/Safety lab test equipment and methods

Excellent communication, documentation, and technical writing skills

Proven problem-solving skills with a proactive and collaborative mindset

Strong organizational skills and attention to detail

Ability to work in FDA-regulated environments with cross-functional teams

Education & Experience Requirements:

Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Physics, or a related field

Alternative: Two years of post-secondary engineering education plus two years of hands-on engineering/technician experience

5–8 years of progressive work experience in circuit design, EMC, wireless , and product safety testing

Experience in the IVD or medical device industry is preferred

Additional Attributes:

High integrity and self-motivation

Ability to interface effectively with internal teams and external certification bodies

Experience working in FDA-regulated environments is highly desirable

Knowledge of IVD medical device regulations and directives is a plus