Day to Day:
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 Have s:
- 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.
- Mentors less experienced engineers.