Design Quality Engineer Jobs

Verv is adding to their team!

JOB DESCRIPTION: Medical Device Design Quality Engineer

Verv is focused on creating the first of its kind consumer-oriented, affordable, high-quality blood chemistry analyser with disposable tests for home use, that will help individuals measure a wide range of analytes (i.e., cholesterol, vitamin levels, hormones). Verv will empower consumers, help them take control of their own health, transform access to blood testing, and improve timely decision-making between consumers and their healthcare providers.

We are seeking an experiencedMedical Device Design Quality Engineerwith proven ISO 13485 experience to work with our brilliant team in Sudbury, Ontario, an area known for its pristine nature and affordable housing.

Position Summary:

We are in the commercialization of our technology. In this cross-functional quality role, you will

actively participate in product development and commercialization for our sample-to-answer system.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.

Key Responsibilities

Engineering:

·Provide design control leadership to new product development teams, with ability to help drive the evolution of all components of the system including blood collection, blood plasma separation, test assays for in vitro diagnostic (IVD) applications, the portable reader/analyzer, firmware and software.

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

·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.

·Provide knowledge with respect to the core technology – digital microfluidics, electrochemical cell assays, advanced electronics - to facilitate participation in technical discussions and risk-based decision making.

·Ensure product development and validation programs meet regulatory requirements and align to new or emerging standards (industry/regional/global) for engineering design.

Project Management:

·Responsible for the management of an active set of projects and oversee project execution and maintain project deliverables, budgets, schedule, status.

·Act as primary liaison with 3^rdparty subcontractors who are helping accelerate commercialization of our technology

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

·Ensuring project requirements are clearly identified and stakeholders are kept informed of project status.

·Coordinate team with respect to project demands and facilitating program management functions.

Requirements:

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

·Technical expertise in product development

·Experience in managing design projects, delivering systems in the medical device environment.

·Leadership experience within multidisciplinary development teams and demonstrated ability to lead teams to successful outcomes.

·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

Education:

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

Salary:

$100,000 - $130,000/yrcommensurate with education and experience. This is an ESOP eligible role.

Contact Person: Victoria Coleman

Name of Business: Verv Technologies

Mailing and Street: 56 Walford Rd, Sudbury ON, P3E 2H3

Email Address: [email protected]

We would like to thank applicants for their interest; however only those considered for an interview will be contacted.