Electrical Engineering Team Leader
Reporting to the Vice President of Engineering, the Electrical Engineering Manager will be responsible for design and certification of all electrical aspects of Profound’s medical device. In addition to a university degree in Electrical Engineering, the successful candidate will have training in MRI physics, sound knowledge of electronics engineering design principles for analog, digital and RF mixed signal designs, familiarity with IEC-60601, and at least two years of experience with design and certification of medical devices.
Reporting to Software Team Leader, the Software Developer is a member of a team responsible for the requirements, design, implementation, integration, testing, verification and maintenance of PMI’s software products.
• Requirements analysis and formulation • Software design • Software implementation • Design and implementation of unit tests • Software testing • Software documentation • Software problems analysis and resolution • Software maintenance • Support of Continuous Integration environment
Required Experience and Training:
• 3 - 5 years of industrial experience with emphasize on development for Microsoft Windows Desktop/Embedded platforms • Fluent OOD including Design Patterns • Concurrent software design, implementation and testing • Inter-process communications • Microsoft .Net and Windows APIs • C#, C++ • Microsoft Visual Studio • VCS tools • B.Sc. in Software Engineering, Computer Science or similar
• Software development in highly regulated environments • Exposure to modern software development paradigms: Agile, TDD and CI • WPF, MVVM, WCF, TCP/IP • Windows Installer and Wix Toolset • Integration of 3rd party software components • Experience with 2D and 3D medical image processing is very beneficial
• Detail oriented, highly organized and efficient • Excellent communication skills • Hard working
Quality System Specialist
The Quality System Specialist supports the Quality/Regulatory department as required in all aspects of quality control, quality assurance and regulatory compliance activities.
1. Assist with monitoring and maintenance of the Company’s Quality Management System. Continually evaluate effectiveness of the compliant system and programs.
2. Control and maintain QMS documentation in accordance with internal procedures and external regulatory standards and guidance.
3. Stay up-to-date and follow procedures related to the job.
4. Oversee generation and maintenance of Design History Files and ensure compliance to applicable regulations.
5. Participate in risk management meetings and related activities such as verification of risk mitigation implementation in products and processes.
6. Provide support for the supplier management program. Evaluate suppliers, monitor supplier quality issues, and coordinate failure investigations in a timely manner. Create reports on supplier performance.
7. Maintain equipment calibration program to ensure equipment is calibrated in a timely manner.
8. Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
9. Participate in process validation activities.
10. Participate in documentation and investigation of customer complaints.
11. Maintain Corrective Action and Preventive Action and Non-Conformance processes.
12. Participate in third-party audit and inspection activities (ISO, Notified Body, FDA, Health Canada, etc.).
13. Conduct Internal Quality Audits and support the audit program as needed.
14. Perform training on aspects of the quality system and manufacturing processes as needed.
15. Other duties as assigned.
Education:University or College degree, preferably in sciences or quality/regulatory
Minimum 3 years medical device experience; or equivalent combination of education and experience.
Strong knowledge of device regulations and its applications such as FDA QSR, International Standards i.e. ISO 13485:2003, ISO 14971:2000; Medical Devices Directive (MDD), Canadian Medical Device Regulations (CMDR).
Language Skills: Ability to read, analyze and interpret common business documents. Ability to respond to inquiries or complaints from customers, suppliers, and business partners.
Ability to write well. Ability to effectively present information to management.
Excellent knowledge of Microsoft Office applications such as Excel, Power point, Visio, Word, Access, etc.
Organized, detail-oriented, and able to multi-task and prioritize responsibilities.
Experience in engineering and manufacturing environments preferred.
Experience in quality audits preferred.
Marketing Communications Manager
The Marketing/Communications Manager is responsible for developing materials and interacting with internal and external clients to deliver Profound Medical’s message to the public and media. She/he will provide assistance to senior management with the development of publications and press releases. The co-ordinator is also responsible to maintain the brand integrity of Profound Medical and strategically positioning Profound Medical as a trusted source. She/he is responsible for helping to ensure consistent and cohesive messaging that speaks to the community at large, as well as communication programs (as necessary) within the specified deadlines and budgetary constraints. This individual must be aware of current trends and react quickly to changes in the industry or at Profound Medical.
1. Interact with internal clients and external clients in order to deliver Profound Medical’s message. 2. Conceive, develop, create, edit, produce, implement, corporate communications such as press releases 3. Ability to take media calls, and arrange for media interviews 4. Oversee the development, implementation, management and maintenance of all online communication vehicles, including but not limited to: • Profound Medical website • E-mails • Online social media (including Facebook, Twitter, blogs, etc.). 5. Aid in promoting brand initiatives consistent with corporate business goals and objectives. 6. Research, develop and implement marketing communications strategies and programs, including direct mail, corporate sales, Internet marketing, conventions, workshops, advertisements, sales tools and other initiatives. 7. Identify changes in the market (through the monitoring of various social media sites and online publications). 8. Provide market research supporting any suggestions of new marketing and/or communications initiative. 9. Determine target markets and their various characteristics, aiming to broaden the appeal of Profound Medical’s brand. 10. Determine pricing and profitability margins based on market research and other projections. 11. Develop marketing plans within budget requirements. 12. Other related duties as assigned.
Bachelor’s degree in marketing, advertising, business management, communications or related field.
• 3-5 years’ work experience in a marketing communication manager capacity • Medical device industry experience preferred • Experience and success in writing corporate materials such as press releases • Strong portfolio of writing samples required. • Bilingual in English and French is an asset • Direct experience with graphic design, Web page, and other marketing-related software tool
• Excellent understanding and familiarity with brand building and brand management. • Superior written and verbal communication skills. • Ability to grasp technical concepts. • Strong morals and ethics, along with a commitment to privacy. • High level of critical and logical thinking, analysis, and/or reasoning to identify underlying principles, reasons, or facts. • Highly effective project management, prioritization, multi-tasking, and time management skills to meet deadlines.