Medical Safety Engineer

Intertek

10d•Onsite

About The Position

Intertek is seeking an Engineer-Medical Safety to join their Electrical team in Boxborough, Massachusetts. This role involves performing testing and evaluation on medical devices and products to ensure compliance with U.S., Canadian, and international product safety standards. The position offers an opportunity for career growth in product testing and regulatory compliance, contributing to international trade and product success. Intertek is a Total Quality Assurance Provider with a global network of laboratories and experts dedicated to quality, safety, and sustainability.

Requirements

Bachelor's degree in engineering
No experience required - recent college grads considered
Must be detailed-oriented and able to effectively prioritize and organize workload, with efficient time management
Ability to define problems, collect data, establish facts and draw valid conclusions
Ability to make technical decisions and engineering judgments independently within established parameters
Ability to communicate and interact effectively in both verbal and written format
Must be self-motivated and able to work independently in a fast-paced, multi-tasking environment
Physical dexterity to perform the clerical and technical functions which are inherent to the position
Physical dexterity to operate equipment and perform other functions necessary to effectively and efficiently perform the duties of the job. This may include bending/stooping, turning/twisting, reaching, balancing, and mobility to travel to other work sites.
Working knowledge and proficiency with Microsoft Office, including Outlook, Word, Excel and PowerPoint
Valid unrestricted driver’s license and reliable driving record
Ability to travel as business needs dictate, up to 15%

Nice To Haves

Bachelor's degree in electrical, mechanical or biomedical engineering
Experience with U.S.A., Canadian, and other international product safety standards such as; ISO 14971, IEC 60601-1, IEC 60601-1-6 + 62366, IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-11, IEC 62304, IEC 60601-2-25, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-46, IEC 60601-2-49, IEC 60601-2-52, ISO 80601-2-56, ISO 80601-2-61, etc.

Responsibilities

Independently perform testing and evaluation on a variety of medical devices and products to the requirements of U.S., Canadian and other international product safety standards.
Write reports and communicate with clients.
Independently conduct on and off-site evaluation of products to determine compliance with applicable standard(s).
Read and determine applicability of national codes and standards clauses for the EUT (equipment under test).
Supply information for quotes such as length of project, site needed, rental equipment, samples, and standards that will be used.
Set up and operate standard test equipment including, but not limited to spectrum analyzer, oscilloscope, multi-meter, dielectric strength tester, ground continuity tester, digital multi-meter, surge generator, over-voltage tester, environmental condition chamber, and articulated probes.
Use hand tools to build/calibrate test fixtures.
Develop, set up, and follow established test plans.
Perform testing of products in accordance with standards. Core tests include, but are not limited to rating, leakage current, dielectric, temperature, pressure, stability, mechanical hazard, flammability, abnormal and fault insurance, rain, radiation, sound, and laser.
Communicate project status and test results to client, sales personnel, and management throughout testing.
Provide on-going support to clients as needed.
Perform other work as required.