A medical device company located in Lakewood, CO is looking for a Design Quality Engineer to join their team. The Design Quality Engineer (DQE) exhibits a robust understanding of engineering principles and practices, applied across various assignments and related fields, all within a collaborative team environment. The DQE will be at the forefront of representing design quality in our organization. This is a pivotal role in shaping quality plans and establishing criteria for diverse products and design activities. This position presents a unique opportunity to make a meaningful contribution to the mission of enhancing patient care through technological advancement. The pay rate for this role is between $123,000 to $154,500.
Must Haves:
Bachelors of Science
8+ years of relevant experience
2 years of experience of GMP experience
Plusses:
Masters in Engineering
Essential Duties:
Quality Management and Compliance
Supporting the Global Quality Management System (QMS) by comprehending its requirements, escalating compliance concerns when needed, and ensuring adherence to regulatory standards.
Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
Ensures completion of CAPA activities including facilitating root cause analysis and leading cross-functional teams for implementation.
Ensures compliance with global QMS procedures - design and development, inclusive of design change control.
Supports external QMS inspection and audit.
Software Development Process
Demonstrate a strong grasp of both agile and waterfall methods of development.
Ensure alignment with project timelines and design controls deliverables within these frameworks and the compliance to regulations and objectives.
Assess and critique the thoroughness and effectiveness of project software testing methodologies.
Device Support
Supporting physical devices focusing on quality for embedded software development and testing.
Ensures a comprehensive understanding of hardware and software interactions to identify potential system design failures.
Facilitates and manage risk management activities.
Actively participate in new product development and engages with cross functional partners in the development phases to develop strategies, risk management activities and verification and validation test strategies.
Propose enhancements to improve design requirements, design implementation traceability, testing accuracy and reliability.
Critically analyze whether the software is performing its intended functions correctly.
Ensures comprehensive identifying, documenting, and tracking software defects in devices.
Design Quality Leadership
Conducting complex or novel research assignments that require the development of new or improved design quality techniques and procedures.
Employs an in-depth knowledge of cross-functional areas, applying knowledge to other technical domains.
Guides the successful completion of design quality deliverables for major programs; may function in a project leadership role.
Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to design quality problems encountered in projects.