Principal Software Design Quality Engineer-Medical Device

MAJOR JOB OBJECTIVES

The Principal Software Design Quality Engineer will work as a member of a cross-functional project team engaged in new product development.

The individual will serve as a quality representative on product development programs and will work closely with Project Management, System Engineering, Software Engineering, Engineering, and Manufacturing.

This individual will be responsible for providing quality leadership, guidance, and support in quality system methodologies for ensuring that the medical device and software development deliverables are executed and released that meet customer expectations, regulatory requirements, applicable standards and company policies and procedures.

This role will be a key member of product development teams and will have the opportunity to influence the product design direction based on the customer needs, product reliability expectations, and performance requirements.

PRINCIPAL RESPONSIBILITIES

The Principal Software Design Quality Engineer will be responsible for providing quality leadership, guidance and support in quality system methodologies for medical device product and software development.

This includes:

Serve as the quality representative on development teams engaged in new product development of medical devices and medical device software.

Support design and development planning, design input and design output activities, risk management activities, Design and Development File management, design transfer activities, change management, and design reviews for medical devices and medical device software.

Lead Quality Assurance programs and ensure plans are in place to provide and maintain the quality levels for assigned projects in accordance with regulatory requirements, contractual requirements and product specifications.

Ensure products are developed and released that meet customer expectations and regulatory requirements including 21CFR820, ISO 13485, ISO 62304, and ISO 14971.

Support development and approval of design verification and design validation documentation, risk management documentation, product documentation, specifications, and drawings.

Support process development, test method development, and associated validation activities.

Use statistical tools and techniques to analyze and evaluate trends, investigate failures, determine root cause and take appropriate corrective actions to prevent recurrence where appropriate.

Oversee qualification and testing requirements, initiate required customer reports and lead/support corrective action efforts on failures/defects.

Experience in developing or enhancing risk-based product and software development processes that meets global regulatory standards and regulations.

Supporting software tool development and validation.

Facilitate integration of new products into manufacturing.

Ensure company policies, procedures, practices and facilities comply with all applicable customer and regulatory re...