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.
Quality Engineer - Medical Device
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. Bachelor of Science degree or Master of Science degree in Engineering or computer science preferred Stron...
Quality Engineer - Medical Device
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. Bachelor of Science degree or Master of Science degree in Engineering or computer science preferred Stron...
Quality Engineer - Medical Device
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. Strong in design quality for embedded medical device software or software development for devices. Collaborate with ...
Medical Device - Dev Quality Engineer 2
We’re seeking a Dev Quality Engineer II to join the New Product Development team to ensure the quality and safety of their medical devices throughout the product development lifecycle. Development Quality Engineer II. HireMinds is proud to partner with a leader in medical device innovation, focusing...
Device Engineer (Quality Assurance Engineer)
Device Engineer (Quality Assurance Engineer)</b></p> <p><b>Denver , CO ( 4 Days Onsite try and find someone local to CO)</b></p> <p><b>Visa : No H1B</b></p> <p><b>Duration : 6 Months</b></p> <p><b>Moi : S...
Quality Engineer - Weld Inspections NACE and SSPC standards
Reviews project specifications to identify quality compliance requirements, communicates with sales and project management department to ensure clear understanding of scope related to quality. Generate nonconformance reports and communicate with internal cross functional team of Project Engineers, B...
Unemployment Insurance QA Analyst
A company is looking for a Quality Assurance Analyst to support the Unemployment Insurance Modernization Project. ...
Sr. QA Analyst
QA Analyst, you will be instrumental in Vertafore’s ongoing success within the insurance industry. Our QA Analysts work with our development teams, focusing on the providing the best products for our valued customers. ...
Senior Mechanical/Process Engineer
Forte Dynamics is a consulting and engineering firm that specializes in mineral resource and reserve estimation, mine planning, blasting analysis, metallurgy, process design, recovery modeling, basic and detailed engineering, and construction management services. Senior Mechanical/Process Engineer&n...
Senior Mechanical Engineer
This position is for a candidate with 10+ years of experience performing functions which require the application of standard mechanical engineering techniques, procedures and criteria in performing a sequence of related engineering tasks. We are looking for a Senior Mechanical Engineer with Power Ge...