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.
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.
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
Cross-functional team player
Strong problem-solving skills
Project management and organizational skills to handle multiple priorities