Sr. V&V Engineer

2 months ago

Andover, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities and Requirements:
  • Collaborates as a key member of the R&D, Systems and V&V teams to ensure that product requirements are relevant, testable and measurable.
  • Defines, plans and leads activities, including, test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification or Design Validation.
  • Authors and executes Design Verification plans or protocols to ensure design input requirements are satisfied to all relevant Quality System and regulatory requirements.
  • Defines and leads the execution of a suitable product reliability test plan to critically evaluate system performance and reliability, ensuring that the product is adequately pressure-tested to satisfy user, regulatory and business requirements.
  • Leads the execution of IEC 60601 mechanical safety testing relevant to the product profile, working with external lab vendors to ensure appropriate product certifications.
  • Ensures Design Verification testing is performed with sample sizes that meet the requisite confidence level and reliability, proportional to the risk assessed for the relevant design inputs.
  • Authors Design Verification test reports to support regulatory submissions for new products, derivative products or regulatory approvals to expanded geographical regions.
  • Implements DFSS rigor throughout the design selection and development process, leveraging and deploying empirical, statistical and analytical tools which will improve design decisions and reduce design iteration cycle times.
  • Synthesizes, develops, updates and optimizes designs that meet requirements by understanding design space with design options and tradeoffs, managing critical parameters, leverages strong engineering fundamentals and tools and integrating manufacturing principles early in the development.
  • Bachelor's degree in mechanical engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering or related field.
  • 10+ years of professional experience leading or supporting product development projects, including electrical and mechanical systems.
  • 5+ years of experience with leading or executing Design Verification of disposable electromechanical medical devices.
  • Practical experience with various elements of the New Product Development (NPD) process; including design lifecycle phases and product design qualification to make regulatory submissions (US -FDA or other geographic region agencies).
  • Experience with defining and executing testing regimen to demonstrate compliance with IEC 60601 for mechanical safety/essential performance.
  • Demonstrated experience with developing and executing product reliability test plans for both durable and disposable medical devices.
  • Experience with implementing product changes through a structured, phase-gated product development process that compiles with FDA regulations for Design Control.
  • Proficiency with statistical techniques including familiarity with Gage R&R, Reliability, analysis of variance (ANOVA) and design of experiment (DOE) methodologies.
  • Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions.
  • Leadership and team building skills.
  • Working with regulatory standards.
  • Strong project management skills.
  • 10+ years of post-educational experience in Medical Device Design highly desired.
  • Experience as a lead in the development of medical disposable devices highly desired.
  • Experience with software or firmware development compliant with IEC 62304 highly desired.
  • Six Sigma certification training / experience.
  • Pharmaceutical Infusion pump development experience.
  • Expertise in common risk management techniques highly desired.
  • Established expertise in leading engineering analysis to predict behavior of proposed designs with analysis tools based on analytical or computational methods (e.g. Minitab, Matlab, etc.).
  • Demonstrated deep understanding of establishing project and product requirements.
  • Regulatory standards (21CFR 820, IEC 60601, ISO 14971, ISO 13485), and system level V&V planning and execution.
  • Knowledge of Design for Six Sigma (DFSS) methodology.
  • Excellent verbal and writing skills.
  • Highly collaborative both within the function and with other functions.
  • Advanced technical and managerial judgment; advanced problem-solving skills.
  • Self-initiator, results driven and action & detail oriented.
  • Disciplined and well organized.
  • Demonstrated learning agility of new subject matter.
  • Understanding and use of an innovation process utilizing elements of search, synthesis, and select.
  • Strong passion for the diabetes epidemic and motivation to simplify the management of diabetes.

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