Senior Engineer, Design Assurance

The Sr. Design Assurance Engineer supports Cantel Medical's Product Development and Sustaining Engineering teams. Position plays a key technical leadership role in Cantel's Product Development and Design Control processes. Responsible for engineering activities including participating in review and gap assessment of design requirements, development, execution and maintenance of risk management plans and activities, identification of applicable standards, review of component and system level specifications, test method development, test plan and protocol development for Design Verification and Design Validation activities, data review and analysis from key testing activities, participating in Design Stage Reviews and process validation activities related to Design Transfer to Manufacturing.

What you will do

Work with Cantel Medical Product Development team to execute risk based approach/procedure/plan to develop/design requirements/specifications, technical standards, test methods, test plans, test protocols and test data analysis.
Interact with external customers on significant technical matters that may require coordination between organizations.
Develop Test Plans and protocols independently and/or in partnership with R&D subject matter experts, conduct verification test execution and report generation.
Build design assurance plans for electrical, hardware and software - including Board level design, DSPs and FPGAs. Provide quality assurance & technical support for Track & Trace software and work closely with Technical services group for Pre-testing prior to deployment at Beta sites and the Field.
Familiarity with standards used in medical grade software development and apply them for Design Assurance.
Responsible for the identification of technical standards against QSR, EPA, EU MDD/MDR and other target market regulatory and clinical requirements.
Responsible for partnering with Product Development teams and Supply Chain personnel in the assessment of component and system level specifications relative to customer needs and product performance specifications.
Apply Design for Reliability and Manufacturability tools and techniques to ensure Cantel product designs are robust, fit Cantel's manufacturability model, and meet customer needs.
Provide effective Design Quality Engineering support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations.
Collaborate with R&D, Marketing, Regulatory Affairs, Supply Chain and Manufacturing to ensure effective and robust risk management, testing, verification, validation, IQ/OQ/PQ as applicable for products and processes from the concept to market phases of product development.
Assist in continuous improvement activities as necessary and as driven by product lifecycle management that generate Sustaining Engineering projects.
Prepare oral and/or written reports of analysis for Design Verification, Design Validation and other critical testing and evaluation activities, as required by the project or department management.
Update job knowledge by keeping abreast of trends and developments in design quality assurance, statistical analysis, test development, ISO 13485, ISO 14971, TGA, Health Canada, FDA quality systems regulation (21CFR820), and EU MDR, and participating in educational opportunities.

What we are looking for

BS degree in Biomedical/Electrical/Computer Engineering/Mechanical Engineering required. MS degree preferred.
8 plus years Design Quality Assurance experience in a regulated medical device environment, specifically in a product development support role
Design and testing experience in electrical engineering and SW/hardware - including Board level design, DSPs and FPGAs
Experience in responsibility for compliance to FDA QSR, MDD/MDR and ISO regulations
Experience in responsibility for medical device Design Verification and Validation activities
Experience in and responsibility for product and process risk analysis/FMEA, requirements writing, test method development and validation, statistical analysis of quantitative and qualitative data, verification & validation protocol/report writing and medical device design reviews.
Previous work experience in life science products and/or medical device fields is required
Previous work experience with IEC standards including but not limited to IEC 61010, IEC 60601, IEC 62304
Proficient in computer skills such as MS office programs

PREFERRED QUALIFICATIONS:

Strong written and oral skills
Strong organizational and management skills
Strong problem-solving skills
Strong attention to detail
Strong knowledge of Reverse Osmosis Systems