Software Quality Control Engineer

The Product Development team at StarFish Medical is growing, and we have an opportunity for a Software Quality Control Engineer in Toronto, ON. In this role, you to test, verify, and validate medical devices and systems developed at StarFish Medical to meet international regulatory standards in conformance with the StarFish Quality Management System. This includes contribution to the design of cutting-edge, ground-breaking medical products and novel technologies from the initial concept stage through to a complete release to manufacturing.

As a Software Quality Control Engineer on the product development team, you will be collaborating with other disciplines, departments, and external development partners and mentoring and sharing knowledge with others, so excellent communication skills and the ability to build relationships is required. You will enjoy diversity in tasks including assisting business development and project managers by developing quality control tasks and estimates for customer proposals, and providing content for design documentation including contributing to formal design and source code reviews. You will also participate in Technical and Design Review activities for Product Design.

If you bring 5+ years of experience testing software-based systems, with experience working with a Quality Management System (QMS) in a highly regulated industry highly desirable, then we would love to hear from you!

StarFish Medical will offer you:

• Satisfaction of helping others through medical device technology
• An organization with strong core values
• A team-oriented/collaborative environment
• Award-winning company culture and engaged team
• Profit sharing
• Competitive compensation
• Excellent benefits package
• Monthly All-hands meetings
• 50% BC Transit/TTC cost sharing.
• Both locations offer shower facilities for midday runs or biking to work, Victoria offers Galloping Goose access close by, and Toronto offers a Bike Share station within a 5-minute walk to the office.
• Both locations offer free parking on-site or around the premises.
• An active social committee with events happening both during the workday and outside work hours. Some events cater to the individual, and others to their family.

Your day as a Software Quality Control Engineer may include:

• Helping ensure Quality Control in the development of software for complex medical devices and systems by planning and execution of quality tasks.
• Reviewing and updating Design History File (DHF) documentation to ensure and control the quality of Requirements, Architecture, Risk Analysis, Technical Requirements, and Verification Plans.
• Contributing to Design For Testing (DFT) and Design for Manufacturing (DFM) Reviews.
• Carrying out Unit and Integrated System Verification and Design Validation.
• Contributing to Verification and Design Validation Plans to ensure Product Safety and Efficacy of Requirements and Specifications.
• Contributing to detail-oriented root-cause analyses of medical device performance and failures.
• Writing Verification and Design Validation Reports.
• Contributing to the maintenance and improvement of the StarFish ISO13485-certified Quality Management System.

Our ideal candidate brings:

• Bachelor’s degree in Technical Certification in Computer Science, Engineering, Physics, or equivalent.
• 5+ years experience testing software-based systems.
• Strong ability to prioritize responsibilities and be highly flexible in a demanding product development environment.
• Excellent communication skills, both written, and oral.
• Eligible to work in Canada.

Additional experience that is desirable:

• Experience working within an ISO 13485 Quality Management System, or in a highly regulated industry, such as: automotive, aerospace, medical.
• Web-based application testing.
• Experience in Fault Tolerance and Design for Testing.
• White-box testing (Unit testing) for software applications.

If you would love to be part of the innovation, excitement, and award-winning culture found at StarFish Medical, we encourage you to apply!

Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply for jobs unless they meet every qualification. At StarFish Medical, we are dedicated to building a diverse, inclusive, and authentic workplace. If you’re excited about this role, but your experience doesn’t align perfectly with every qualification, we encourage you to apply anyways. You may be just the right candidate for this or other opportunities at StarFish Medical. Please apply through the StarFish Medical Portal.

If you experience any difficulties with the StarFish Medical Job Portal, please reach out to careers@starfishmedical.com with the subject line “Software Quality Control Engineer | Job Portal Issue.”

We thank all candidates who apply; however, only those selected for further consideration will be contacted after initial acknowledgment. No phone calls, please.

We look forward to meeting you!

About StarFish Medical 

StarFish Medical is a leading North American contract product development and prototype/low-volume manufacturing firm with an award-winning culture focused on the medical and bio-device spaces.  We tend to work on complex electromechanical devices across all medical specialties.  We have over 200 staff located in two main offices in Victoria and Toronto, Canada, and business development staff across the US and have been in business and growing for 23 years.  Our values include innovation, transparency, being aspirational and efficiency. Our job is to enable entrepreneurial medical device companies to improve medical care as their lean med-tech start-up partner assisting them in moving from idea to commercialization with as much founder value intact as possible.  Balancing our innovation mandate with reliable execution is a never-ending challenge.  We need to be consultative and help our clients become valuable and successful, sometimes in ways they didn’t imagine at the beginning, delivering that value in meaningful and powerful ways to them and their investors.  In addition to product development, we also supply intellectual property, regulatory, quality assurance, manufacturing transfer and optimization, supply chain and other complementary services.  We are known for innovation, technical excellence, service-oriented culture, and operational systems.