Design Quality Engineer

SummaryFunctioning as a core R&D team member, learns and applies relevant subject matter expertise to plan and lead assigned projects, developing new concepts from customer requirements and initial design to clinical commercialization of new medical device products as solutions to customer needs. Primary focus is on oversight, guidance, development, and critical review of formal design history documentation through all phases of research and development.Essential Duties and Responsibilities Business Development / Technical Feasibility EvaluationAnalyzes product proposals, initial requirements, and conducts feasibility studies to determine viability of potential designs or applications in conjunction with estimating development time, budget, and unit cost for scope of work.Investigates, evaluates, and implements existing or emerging technologies, and innovates solutions for new product ideas. May conduct market and intellectual property research and analyses to generate recommendations for product solutions.Project Management / OversightContributes to definition of design input requirements to ensure designs are fully defined, will meet user needs and intended uses, meet defined regulatory requirements, and can be appropriately verified.Acts as technical subject matter expert for assigned projects, drawing upon external resources for expertise as needed. Represents R&D on cross-functional teams.Performs effective project planning and management activities, acting as lead on assigned projects.Coordinates with internal and external project stakeholders, as needed, concerning technical developments, scheduling, and resolving engineering design and test problems throughout the design and development process, including transition to production.Communicates project status, metrics, major issues / mitigations, etc. to engineering management, other project stakeholders, and executive management.Design and DevelopmentGuides prototyping approach and methods, in collaboration with project team and stakeholders, to best meet overall project needs and milestones; such as for feasibility studies, system evaluations, design testing, formal verification, etc.Contributes to detail design activities in area of expertise.Liaises with external design services to provide input, perform critical review, and ensure that design output meets project and manufacturing requirements.Designs, executes, and documents experiments, high level plans, advanced test protocols, and performance evaluations to verify that designs meet input requirements and to validate that the product or subsystem meets the intended use.May source and coordinate supplier activities for specific materials and components under development, including for contract testing services, to ensure the delivery of supplies or services needed to meet scheduled timelines.Application of Design Controls / DocumentationUnderstands and implements the processes and intent of all aspects of QMS-based design controls.Contributes to development and maintenance of guiding SOPs and administration of productivity tools.Ensures development activities are documented consistent with formal Quality Systems, providing oversight and critical input and review; including definition of product requirements, project planning, design output (production drawings, specifications, bills of materials, assembly and QC procedures, inspection criteria, etc.), design review, design verification and validation, change control, design transfer, and risk management.Creates and maintains Design History Files for assigned projects and may lead associated quality system audit defense of design controls.Assists with related special projects, as required.QualificationsEducation and ExperienceBachelor's degree (B.S.) or higher in Biomedical Engineering, Medical Device Engineering, or core engineering or scientific discipline from a four-year college or university, and at least five (5) years of experience developing, designing, or supporting medical device products.Experience with one or more full product development cycles.Ability to multitask and contribute to multiple projects as needed.Demonstrated critical thinking and analytical problem-solving skills.Excellent detail, organizational, and time-management skills, with a strong sense of responsibility and adherence to deadlines.Excellent technical writing skills are necessary to succeed in this position.Working within design control requirements of ISO 9000 or ISO 13485 Quality Management Systems.Medical Device Experience (working under FDA cGMP, IVDR, MDR, etc.) for Class I and II devices.Competence in application of ISO 14971 risk management principles to medical device design.Preferred Experience and SkillsSystem-level design experience, including overall project ownership.Understanding and functional knowledge of the statistics of quality as applied to medical device development (e.g. for development of verification protocols and criteria).Experience using and adapting standard test methodologies to design verification (e.g. ASTM, CLSI, etc.)Root cause investigation and analysis and ability to test and troubleshoot complex systems.Working knowledge of design and testing to meet regulatory compliance standards.Prior contribution to quality processes for control of design and development.Exposure to general operations / manufacturing environment.Working in globally distributed teams.