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Job Title:                               Design Assurance & V&V Engineer

Functional Area:                   Product Quality Assurance

Reports to:                             Director of QA/RA

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OVERVIEW:

CTF MEG International Services is a high-technology developer/manufacturer of brain imaging systems. This position will involve working across functions as part of a team to assure that the design of MEG and EEG systems for new applications and product sustainability initiatives are compliant with all applicable quality and regulatory requirements.  Responsible for providing input into the design process, establishing and maintaining the accuracy of Design History File documentation, product V&V and compliance testing scheduling & management, process validation, and assuring overall compliance of the product development lifecycle.

RESPONSIBILITIES:

• Accurate synthesis of Design History File documentation and overall Quality System compliance of product development activities, comprising hardware (electronic, mechanical), firmware and software components.

• Following all applicable design control procedures and other quality system requirements at each stage of the engineering process

• Working with staff on forming and completing documentation which is compliant with the product development procedure

• Generating and documenting system requirements and detailed specifications.

• Synthesis, review and approval of design verification and validation plans, protocols and test reports covering bench and system-level testing

• Ensuring that all project quality-related documents are created and well managed according to the regulation and internal quality standards

• Ensuring all project and quality documents are complete, current and stored appropriately

• Participating in risk management sessions and assuring documentation to support risk management is complete

• Approving quality documents related to the design assurance projects

• Managing and monitoring day-to-day project documentation

• Participating in design review sessions and CAPAs as required

• Designing and implementing IQ/OQ/PQ protocols for production equipment and process validation

• Sourcing and evaluating new parts and components

• Ensuring conformance of designed product with all applicable standards, including compliance verification testing, both in-house and at testing laboratories

• Transferring design to manufacturing, including writing MPs, in-process test procedures, final acceptance procedures, service and installation procedures, IFU, implementation and qualification of testing and programming tools

• Other duties as assigned.

QUALIFICATIONS:

• BS in Engineering (electrical, mechanical, biomedical, engineering physics) or equivalent

• Proven success working in multidisciplinary roles

• 5+ years’ experience having direct involvement with medical device product development and testing, including Class 2 medical devices and software lifecycles

• 5+ years’ experience having direct involvement with medical device risk management processes

• 5-7 years’ experience in creating and approving medical device documentation

• Experience with medical device regulations and standards, such as ISO 13485 and CFR 21 Part 820, IEC 60601, ISO 14971, IEC 62304, IEC 62366

• Proficient with statistics, statistical tools and software

• Hands-on experience with process Development, Characterization and Validation

• Proficient utilizing Microsoft Office (Word, Excel, PowerPoint and Visio)

• ASQ Certified Quality Engineer is a plus

• Communication skills: Good communication (oral and written) skills to facilitate productivity in a small team environment, formal design documentation

• Self-driven to excel in an intuitive, passionate, and highly collaborative team-based organizational culture

• Analytical skills: troubleshooting designs and product problems, understanding the impact of design changes to current products, understanding logistics of manufacturing

• Leadership skills: the ability to train others on product design

• Experience in risk management methodologies, including the application of FMEA, FTA and HAZOP to medical device design

ASSETS:

• Cross-functional team player

• Strong problem-solving skills

• Project management and organizational skills to handle multiple priorities

Job Posting Response Information:

Reply by submission of resume (no phone calls) to:

Design Assurance & V&V Engineer

CTF MEG International Services LP

Unit 7 – 68 Schooner Street

Port Coquitlam, B.C.

V3K 7B1

e-mail: employment@ctfmeg.com