Quality Engineer III, Design Assurance - Hardware

Position Summary

The Hardware Quality Engineer fulfills hardware design assurance (i.e., quality and compliance of design) role on new product development (conception to launch) and sustaining projects for stand-alone capital equipment. Contributes to planning and execution of design controls, risk management, test method development and validation, and design verification/validation for new and existing products. Supports Regulatory Affairs with creating submissions and responding to submission questions. Develop, document, and optimize new product development deliverables and processes, accounting for cross functional system interactions.

Principal Responsibilities

•    Understand product user needs and assure they are translated to the design, while ensuring compliance to usability and human factors standards and regulations.
•    Contribute to new product development Technical Reviews and Design Reviews.
•    Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships. Develop the strategy and manage the execution of design verification and validation.
•    Generate, review, and validate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing related to hardware including mechanical and electrical. 
•    Design test equipment, test fixtures, and testing hardware using multiple types of equipment such as, oscilloscopes, meters, power supplies, and signal generators. 
•    Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA). 
•    Develop and maintain the product risk management file, including updating based on post-market information.
•    Understand and assist in applying supplier management principles such as supplier selection, qualification, certification, and performance improvement. Familiarity with IPC-610, IPC-620, J-STD-001 preferred. 
•    Support regulatory approvals and responses to regulatory questions.
•    Assure quality of the Sustaining Engineering process for design and process changes to commercialized product.
•    Review and improve design assurance-specific quality system deliverables and processes to increase effectivity and efficiency.
•    Assure quality in the transfer of new product development projects from development to production. Assist with process validations and control plans.
•    Produce Design History File (DHF) and Device Master Record (DMR) documentation per quality system requirements.
•    Support investigations of product performance issues including NC’s and CAPA’s. Utilize systematic problem solving/root cause analysis and quality and statistical tools.
•    Support internal and external audits.
•    Interface with cross functional groups including R&D, Program Management, Operations, Quality Assurance, Regulatory, Marketing, and Supplier Quality.
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences; Electrical, or Biomedical Engineering degree preferred.
•    Three years of related experience in a regulated industry (e.g., military, automotive, aerospace); medical device and design assurance preferred.
•    Advanced degrees and certifications are a plus.
 

Specialized Skills / Other Requirements

•    Understanding of applicable standards and regulations such as IEC 60601, IEC 62366, ISO 14971, ISO 13485, and FDA QSR’s.
•    Knowledge of electrical and electronic manufacturing processes as they apply to the design process.
•    Understanding of the systems engineering product development cycle.
•    Ability to utilize applied statistics in data analysis, design of experiments, reliability engineering, measurement systems analysis, and sample size determination.
•    Ability to work independently and with minimal direction.  
•    Organizational ability to define and manage individual and team tasks.
•    Effective verbal and written communication, proficiency in technical report writing and review.
•    Excellent interpersonal skills for working in a team and as an individual contributor.
•    Structured and methodical problem-solving approach.
 

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Working Conditions / Physical Demands

TRAVEL REQUIRED: 5% - 20%

WORKING ENVIRONMENT:
☒ Office/Professional        ☒ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory