Title : Quality Engineer - Medical Device
Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.
Location : Lakewood, CO - on-site 3 days / week
Type : Direct Hire
Shift / Schedule : M-F 8am 5pm
Salary : $123,600.00 - $154,500.00 with 10% bonus
Overview :
Our well-established medical device client is seeking a Design Quality Engineer (QE), who will ensure high-quality medical devices by driving design, development, and risk management.
You will focus on areas including software, electromechanical devices, and disposable products.
Responsibilities :
- Collaborate with I&D teams to bring medical devices to market.
- Evaluate Design and Development deliverables to ensure high-quality products meet customer needs.
- Support SW development improvements in agile environments while complying with medical device regulations.
- Anticipate roadblocks and provides direction for navigating the quality system.
- Ensure thorough root cause analysis for design changes or validation failures.
- Translate critical design attributes to design outputs.
- Guide major programs and may take on project leadership roles.
- Act as the prime technical contact, coordinating with external teams on significant matters.
- Develop technical specifications and ensures regulatory compliance (FDA).
- Direct phases of complex engineering work, developing new approaches to problems.
- Create new processes impacting multiple disciplines.
- Contribute to business objectives, goals, budgets, and costs.
- Present complex technical information and responds to inquiries.
- Mentor junior engineers and provides cross-functional guidance.
- Consult on broad technical and industry issues.
- Work on complex issues requiring deep analysis and judgment.
- Oversee technicians and junior engineers.
Requirements :
- 8 years of experience, including 3-4 in medical devices (quality for design and development in R&D or quality).
- Bachelor of Science degree or Master of Science degree in Engineering or computer science preferred
- Strong in design quality for embedded medical device software or software development for devices.
- Understanding of software functionality.
- Experienced in risk management and product development as a development or design quality engineer.
- Hands-on with test method validations; product knowledge required beyond document review.
- Familiar with software development and agile methodologies.
- Knowledge of 21 CFR 820.30, ISO 13485, ISO 14971, and ISO 62304.
- Skilled in technical innovation and leadership in mechanical / chemical engineering, fluids engineering, and cellular biology.
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