Hardware Test Engineer
TLDR
Design and test hardware components for next-gen medical devices, focusing on quality assurance and regulatory compliance while collaborating across teams.
Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects.
If you share our values and want to work in a collaborative results-focused culture and want to make a profound impact in healthcare and your career, here is your chance.
General Accountability
The Hardware Test Engineer is responsible for designing hardware test procedures and testing mechanical, electrical and electronic designs to support the Company’s Quality System. The Hardware Test Engineer acts as the subject matter expert on all testing prior to design implementation for manufacturing. They are responsible for sustaining and upgrading test design to ensure Quality standards are being met.
Duties and Responsibilities
- Perform hardware testing activities, including (re)design, debugging, modification, and verification of hardware components for company products.
- Develop, update, and execute test procedures, including component and system-level verification testing, and prepare verification plans and reports.
- Report defects in the defect tracking system and verify corrective fixes.
- Develop manufacturing and test instructions and support manufacturing activities as needed.
- Transfer designs to in-house or contract manufacturing and act as liaison with contract manufacturers to resolve design issues identified during testing.
- Participate in and occasionally lead design reviews, providing expertise in hardware design and testing.
- Contribute to system requirements and specifications for device development.
- Ensure all design work complies with Profound Medical’s Design Control Procedures and applicable regulatory standards.
- Ensure electrical safety, support risk management and usability engineering activities, and participate in device safety assessments.
- Work with certification laboratories to test and certify products to applicable safety and EMC standards and ensure compliance with environmental regulations (RoHS).
- Investigate product complaints, perform root cause analysis of failures, and implement corrective actions in a timely manner.
- Lead hardware improvement projects as required by business needs.
- Travel (20–50%) to support testing, certification, manufacturing, and other business activities.
Education
University degree in Electrical/ Biomedical Engineering.
Key Attributes
- 2–3+ years of experience in hardware testing within the medical device industry or other regulated environments.
- Strong knowledge of test engineering principles for analog, digital, and RF mixed-signal designs.
- Experience with electrical/RF engineering for MRI-compatible devices is an asset.
- Familiarity with the IEC 60601 family of standards and regulatory requirements for medical devices.
- Experience in EMC design and testing.
- Solid understanding of MRI physics.
- Demonstrated ability to design, test, and deliver high-quality products within defined timelines.
- Strong analytical and creative problem-solving skills with attention to detail.
- Excellent written and verbal technical communication skills.
- Ability to work effectively both independently and within cross-functional teams.
- Valid driver’s license and passport; ability to travel internationally (U.S. and Europe) on short notice.
We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.
The expected annual salary range for this role is $70,000 - $100,000 CAD. Actual compensation will be determined based on experience, qualifications, and job-related factors. This role may also be eligible for participation in the company’s benefits programs, such as a group RRSP and medical benefits paid by the employer.
We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.
Profound Medical develops innovative medical technologies, particularly for the treatment of prostate cancer, enhancing the standard of care with reliable and effective options. By advancing the TULSA procedure and prioritizing operational efficiency, the company is transforming how medical devices are delivered and utilized, improving patient quality of life.