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RxFunction, Inc. · 9 hours ago

Principal Design Assurance Engineer

Eden Prairie, MN

Full-time

Onsite

Lead/Staff

10+ years exp

RxFunction, Inc. is a company focused on new product development in the medical device sector. The Principal Design Assurance Engineer plays a critical role in ensuring product reliability and compliance throughout the development process, collaborating closely with cross-functional teams.

Health CareInformation ServicesInformation TechnologyMedical DeviceService Industry

Responsibilities

Establish and provide reliability and quality engineering guidance and education to cross-functional engineering staff and technical personnel

Ensure compliance with external and internal requirements related to medical device design and development, good manufacturing practices, and risk management

Serve as a fully engaged and collaborative member of new product development (NPD) and continuation engineering teams by providing innovative ideas and reliability and quality engineering guidance

Employ a practical approach to design assurance and quality by providing technical solutions which are imaginative, thorough, practicable, and consistent with project needs and organizational objectives while maintaining regulatory compliance

Actively support product development projects by coaching teams to create project development plans, design inputs and outputs, design history files, risk management, test strategies and traceability, and verification and validation plans

Support usability engineering and human factors studies to ensure device use errors are minimized or mitigated through standardized approaches

Provide design assurance support for post market surveillance processes when design changes are required

Complete assigned project deliverables that meet all requirements and are on time

Review and approve design and test method verification and validation plans, protocols, and reports. Ensure that test methods are appropriate, adequate, and validated to achieve planned confidence and reliability limits

Actively participate in design reviews and verify completion of all required phase activities and deliverables

Ensure a robust device design by providing effective reliability analysis and test approaches at the component, subassembly, device, and system levels

Identify and evaluate device design, performance, and test requirements propagated by relevant medical device industry, regulatory, and safety organizations to ensure compliance and obtain needed approval, certification, or other authorization

Supervise or execute the investigation, risk assessment, disposition, and correction of nonconforming product. Own all product-related CAPAs

Own, drive, and manage risk management activities related to product design, use, and manufacturing and servicing processes. Support software risk management

Other duties as assigned

Qualification

Biomedical EngineeringQuality EngineeringMedical Device RegulationsRisk ManagementDesign ValidationStatistical AnalysisRoot Cause AnalysisContinuous ImprovementCollaborationCommunication SkillsProject Management

Required

BS degree in Engineering (biomedical, software, electrical, mechanical)

10 years in the medical device industry (FDA or ISO regulated); 10 years as quality engineer supporting new product development or continuation engineering functions

Knowledgeable about medical device regulations, including 21 CFR Part 820 and ISO 13485

Experience with medical device software development and life cycle processes

Experience with medical device safety, including biocompatibility, human factors, hardware, ingress protection, electrical safety, EMC/ESD, stability, and simulated distribution

Proficient in applying design and test method validation methods and techniques, including design of experiments (DOE) and Gage R&R

Experience in applying the appropriate statistical techniques and parameters for a wide range of analyses, including component and design reliability, using statistical software (e.g., Minitab)

Working knowledge of root cause analysis and continuous improvement techniques

Proficient in applying risk / failure analysis methods (FTA, FMEA)

Foster a collaborative, partnering style with colleagues in all functions

Able to work or lead cross-functionally and contribute as an effective team player

Able to handle multiple tasks/projects and manage priorities accordingly

Effective verbal and written communication, analytical, and interpersonal skills