We are excited to be adding to our team with the addition of an experienced Medical Device Quality Design Engineer to work within our lab in Sudbury, Ontario. It is essential to have experience in ISO 13485.

The successful candidate will lead the design control process for the development of the Verv Tech Cholesterol Monitoring System and future tests which utilize on-chip electrochemical assay technology.

Position Summary:

In this cross-functional quality role, you will actively participate in product development and transfer activities for Assays for in vitro diagnostic (IVD) applications. You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure Verv’s products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional core project teams. design control leadership to new product development teams, with ability to work on all components of the system including blood collection, blood plasma separation, cartridge (including digital micro-fluidics and electrochemical cell assays), home use portable analyzer, and smart phone app

· Provide support for project planning, requirements/specification development, product development, design verification, design transfer, process development, process validation, risk management, human factors, and design validation activities.

· Lead product risk management activities.

· Audit the quality and completeness of project design history files.

· Provide consultation to design and process owners with regards to design verification and design validation protocols and reports. Support clinical study planning as needed.

· Act as primary liaison with 3rd party subcontractors who are helping accelerate commercialization of our technologies

· Provide knowledge with respect to the applicable technology to facilitate participation in technical discussions and risk-based decision making.

· Support issue resolution using a risk-based approach.

· Ensure product development and validation programs meet regulatory requirements when applicable.

· Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.

Requirements:

· Sr. Design Quality Engineer: minimum of 5 years of related experience

· Technical expertise in product development

· Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, IVDD, IVDR , and GCP)

· Practical experience in design controls, risk management, verification, validation and change control, and failure investigation tools and techniques

· Applied experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, and trend analysis)

· Medical device and/or lab diagnostic commercialization experience

· Highly effective communication, facilitation, coaching, and negotiation skills

· Adaptable to fast-paced, dynamic work environment with shifting demands

· Demonstrated ability to accomplish goals while working across departments is required

*Applicant must be legally able to work in Canada to be considered.

Education:

Bachelor’s degree or higher in an engineering or technical science discipline

Job Type: Full-time

Salary: $90,000.00-$120,000.00 per year

Benefits:

• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Greater Sudbury, ON: reliably commute or plan to relocate before starting work (required)

Application question(s):

• Have you had experience in Medical Devices and with ISO 13485

Education:

• Master's Degree (required)

Experience:

• Quality Design Engineering: 5 years (required)

Work Location: One location

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