Job Title: Product Development Lead - Medical Device
Job Type: Full-time
Salary: Competitive, commensurate with experience
About Us:
We are a medical device company partnering with a major Toronto hospital to develop a novel treatment for a vision threatening condition. We are seeking an experienced individual with a proven track record in Product Development and Medical Device Commercialization to join our team.
Key Responsibilities:
Medical device product development including:
- Lead the transfer from R&D to Design + Development project.
- Develop productization Plan and Requirements.
- Build Product Design Team with top management.
- Lead the Product Design processes with the team / engineers.
- Build Engineering Prototypes and organize the V&V activities.
- Acquire IEC and other applicable Certifications for the product.
- Lead Risk Management activities in productization.
- Explore, evaluate, control and collaborate with the Suppliers with maintaining quality.
- Organize Design Review processes with top management and quality management team.
- Organize the transfer from Design + Development to Production with the production team.
- Throughout the project, manage, organize and responsible for the Documentation with the team.
- Take charge for Design Control and Engineering Document Control for the quality management audits collaborating with the quality management team.
Requirements:
- Bachelor’s or Master’s degree in Physics, Electrical Engineering or a related field;
- 3+ years of experience in Medical Device product development/engineering;
- 2+ years of experience working in ISO 13485 QMS environment;
- Excellent understanding in basic Physics and Metrology from the first principles;
- Demonstrated Documentation skills and expertise: engineering/design documents, work instructions, journal article publications and/or patent applications;
- Knowledge/experience in Software Development processes and documentation methodologies/practices;
- Strong attention to details; and
- Positive and collaborative mindset working with internal and external stakeholders.
Preferred
- Experiences with Ultrasound physics and/or instrumentation.
- Experiences with Focusing optics with aberrations and diffraction.
- Experiences with Ophthalmic instruments.
- Experiences with 3D CAD Mechanical design (SolidWorks, AutoCAD).
- System development skills with Microcontrollers and Firmware in C/C++ (UART, I2C, SPI, synchronous and asynchronous controls).
- PCB design skills – Schematic, Gerber, BOM (Altium, KiCad).
- Software programming and development skills: Python, Matlab.
- Familiarity with Qt, PyQt/PySide.
- Familiarity with Image Display and Image Processing.
- Experiences/familiarity with university hospital/medical research institute Animal/Human study.
Benefits:
- Competitive salary
- Opportunities for career growth and advancement
- Collaborative and innovative work environment
Job Type: Full-time
Pay: From $90,000.00 per year
Education:
- Bachelor's Degree (preferred)
Work Location: In person
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