Quality Engineer - Medical Device

Title: Quality Engineer - Medical Device

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.