Senior Medical Device Engineer

About EERS
Founded in 2014, EERS is a global Centre of Excellence in Hearing Sciences, with a multidisciplinary team of over 30 engineers and research scientists. We possess unique technology in in-ear voice, noise control, and speech communication, spanning audio, biomechanics, and embedded systems. Our innovative technology enhances human interaction in challenging scenarios through communication, hearing protection, biometric and wellness monitoring and brain-computer interfacing. Our innovations are marketed globally through collaborations with leading OEMs, enhancing communication and hearing health, with several becoming ANSI Standards.

Beginning at research and prototyping, our high-caliber scientists and engineers develop scalable, easily transferable, manufacturable products to our co-development partners, including the Mayo Clinic and Cook Medical.

Our head office is located in the heart of downtown Montreal. We offer competitive salaries, as well as a great team environment of science-minded individuals who come together to solve world problems. EERS Global is an equal-opportunity employer committed to diversity.

Job Description
We are looking for a Senior Medical Device Engineer to join our multidisciplinary R&D team and to design state-of-the-art communication system for use in the MRI room!

Under the supervision of the Principal Designer, you will be playing a leading role in the design, development, prototyping, testing, troubleshooting and manufacturing of a new family of products used for communication in their diagnostic and interventional MRI processes. You will play a pivotal role in impactful work that directly enhances patient comfort and the efficiency of diagnostic processes in MRI suites globally. You’ll have the opportunity to work with cutting-edge auditory and communication technologies, contributing to advancements that set new industry standards. Within our collaborative environment, your fresh ideas will be valued as you join a team globally recognized for its innovative solutions. This role is not just a job; it’s a chance to make a substantial impact in the medical field.

Duties and Responsibilities
• Design, develop, and validate, devices and systems with a view to improving patient outcomes and enhancing healthcare delivery.
• Collaborate with cross-functional teams, including engineers, physicians, and clinical professionals, to understand customer needs and create innovative solutions.
• Lead and execute mechanical product development from concept through to high-quality manufacturing processes.
• Create and maintain rigorous documentation of the design process, develop product specifications, test specifications, and test procedures to ensure that the products comply with the design control process as defined the company’s regulatory strategy and QMS (e.g., ISO 13485, FDA, Health Canada, 510k).
• Conduct design reviews, design verification testing, and risk analysis (DFMEA) to ensure new designs meet performance and safety requirements.
• Generate working prototypes for beta testing and customer demonstrations.
• Provide technical guidance to engineers on the project.
• Qualify and select suppliers.
• Prepare manufacturing documentation package for production.
• Conduct quality control and quality assurance on manufactured goods, incoming and outgoing.

Education
• Bachelor’s or Master’s degree in Mechanical Engineering, or related field.

Qualifications
• 5+ years of experience with product design, development and manufacturing in a regulated field, e.g., medical device industry or a related field (pure academia will not suffice).
• Strong knowledge of medical device development, design controls, and regulatory requirements.
• In-depth knowledge of manufacturing processes: injection molding, machining, additive manufacturing.
• Broad experience in the development of embedded electronic devices, covering RF, EMC, EMI Shielding and Thermal Management.
• Experience with designing and manufacturing small parts within complex assemblies.
• CAD SolidWorks, 3DEXPERIENCE, Rhino and grasshopper.
• Excellent problem-solving and analytical skills
• Excellent written and verbal communication skills in English (French is a strong asset).
• Efficient presentation and visual communication skills.
• Ability to work in a fast-paced and dynamic environment.

Depending on the daily tasks to be performed, working from home may be possible. However, as we often need laboratory equipment and great collaboration between the R&D teams is essential, the hardware designer must be able to come to the office with short notice if necessary. If you are meticulous, a problem solver, and a team player, you will feel right at home. Please send your cover letter and resume to jobs@eers.ca OR submit them through our EERS Career platform.