Lead Design Quality Engineer – Embedded Software & Medical Devices

Title : Lead Design Quality Engineer Embedded Software & Medical Devices

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

Our client is looking for a Lead Design Quality Engineer with proven skills in embedded software coding, design control, and method validation to bring innovative medical devices to market.

In this role, you’ll collaborate closely with cross-functional teams to ensure product design meets both regulatory standards and customer needs.

You’ll lead efforts in agile development environments, manage root cause analyses, oversee design control processes, and validate critical methods impacting device functionality.

This position offers an exciting opportunity to provide technical leadership, mentor junior engineers, and shape quality processes for high-impact 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.

The company provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.

Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.

To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.

For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.