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. System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.