Quality Engineer , Design Assurance

Quality Engineer 2, Design Assurance

Position Summary

• Fulfill 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.

• Contribute to planning and execution of design controls, risk management, test method development and validation, and design verification/validation for new and existing products.

• Support 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.

• Commitment to Goals – A strong commitment to achieving goals is essential for personal and team…