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Hardware Engineering Manager
2 weeks ago
Come Join the THORASYS Team:
THORASYS Thoracic Medical Systems Inc. is a young medical device company based in Montreal's MileEx neighbourhood. We develop, manufacture and market advanced diagnostic medical devices incorporating novel approaches to pulmonary function testing that aid the diagnosis and monitoring of lung diseases such as Asthma and COPD.
We are launching the next generation of our product and are therefore seeking to add an engaged and motivated:
HARDWARE ENGINEERING MANAGER
The position has at least 2 direct reports (electronic engineer and mechanical engineer) and typically includes 1-3 interns. The hardware engineering manager will be responsible for sustaining the hardware components of systems presently on the market, and for the design of new product hardware.
General responsibilities include:
- Lead the electro-mechanical and industrial design of existing and new products, focusing on design for manufacturability.
- Manage hardware R&D backlogs, including organizing and leading sprints and demos.
- Ensure SOPs are properly followed by the hardware engineering team
- Provide information to the project manager to help scope projects, and weekly updates on progress of tasks in active projects
- Assist the Regulatory Affairs/Quality Assurance (RA/QA) with engineering expertise and documentation
- Ensure hardware expenses and resources are effectively managed.
- Train and support to the hardware engineering team, and drive the team to focus on high priority projects as outlined by the VP R&D
As for all THORASYS employees, prioritizing and upholding high standards of security and data privacy in accordance Thorasys procedures and policies.
Competencies and Qualifications
- Strong leadership skills, with experience in leading cross-functional teams
- Excellent communication and interpersonal skills, with the ability to mentor and guide team members.
- Familiarity with conducting technical reviews, risk assessments, and failure modes assessments.
- Ability to write and oversee technical documentation, including design specifications and test protocols.
- Problem-solving skills and the ability to conduct high-level investigations for non-conformities and corrective-preventive actions.
- Proficient in 3D modeling software and design for manufacturability principles.
- Knowledgeable in regulatory requirements and quality systems applicable to medical devices.
Education and experience
Bachelor's degree in Engineering, biomedical specialization an asset.
Minimum of 10 years of experience in a regulated industry (ideally medical device - ISO13485), with a focus on engineering and team leadership.
Experience with electro-mechanical devices including software and firmware components an asset
Report
Unless designated otherwise by the CEO you will report to the VP R&D.
