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Original Job Post

Accordance Search Group · 2 days ago

Principal Design Assurance Engineer

Plymouth, MN

Full-time

Onsite

Senior Level

5+ years exp

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Hiring Manager

Kathy Lane

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Responsibilities

Work with Regulatory, R&D, Engineers, and Product Developers in defining product design requirements and verification/validation methodology and acceptance criteria

Work with Product Developers in defining system architecture to ensure testability of products

Lead adherence to Design Controls throughout product lifecycle

Process owner for product safety risk management (human factors, HW/SW design, process); identifies and implements systemic improvements and supports post-production risk management activities

Provide technical expertise in review of product design documentation and specifications

Support Design Reviews

Review design history files to assure technical accuracy, completeness, and compliance with applicable internal, regulatory and customer requirements

Provide guidance to continuously improve design and development processes

Provide guidance to engineers and product developers on compliance to applicable industry/regulatory product design/performance standards and lead activities to verify standards compliance

Process owner for non-product software and automated systems used in design, operations and manufacturing processes; identifies and implements systemic improvements

Assist in performing usability engineering activities including defining usability evaluation protocols

Participate as a member of new product development teams to influence design robustness, reliability, and safety through application of sounds, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving/preventing design quality issues

Provide input into inspection strategy and plans including working with suppliers on purchased product requirements and development of measurement methodologies

Lead the transfer of specifications and processes to production during design transfer phase

Assist in developing design verification and validation plans, protocols, and reports

Participate in troubleshooting and risk assessment of issues with design team to identify root cause and resolution

Act as key Subject Matter Expert (SME) during audits and inspections for risk management and non-product software validation processes

Participate in continuous improvement of the Quality Management System

Maintain safe and clean work environment

Other duties as assigned by the Director of Product Assurance

Qualification

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Electrical engineeringMechanical engineeringUltrasound physicsValidation testingRisk managementDesign controlQuality management systemsMedical device software developmentFDA Quality System RegulationsISO 13485EU MDRISO 14971IEC 60601 seriesIEC 62304IEC 62366CommunicationTeamworkRelationship buildingAdaptabilityPrioritizationFollow throughMotivationWork ethicAnalytical thinkingProblem solvingAttention to detailOrganizational skills

Required

Excellent written and verbal communication skills and works well individually and in a team with direction, goals, and objectives.

Ability to develop and maintain relationships, internally and externally. Brings a positive attitude and adapts well in a growing environment.

Ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills. Highly motivated, strong work ethic, and efficient.

Strong analytical, critical thinking, and problem-solving skills with an attention to detail and organizational goals.

Basic understanding of electrical and mechanical engineering principles and ultrasound physics

Experience with verification and validation testing, risk management, design control, and Quality Management Systems

Experience with medical device software development life cycle

Experience with FDA Quality System Regulations, ISO 13485 and EU MDR, ISO 14971, IEC 60601 series, IEC 62304, IEC 62366

Advanced degree in a Computer Science, Math, or Engineering (mechanical engineering preferred) related field and five years of relevant experience in the medical device field, or bachelor's degree and a minimum of 10 years of relevant experience