Quality Engineer II
MILLENNIUMSOFT - tempe, AZ
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Position: Quality Engineer II Location: Tempe, AZ Duration: 12+ Months Contract Total Hours/week: 40.00 1st Shift Client: Medical Device Company Job Category: Engineering Level Of Experience: Mid-Seniority Level Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) No H1B's Essential Job Functions: • Provide Quality Engineering representation on various project teams supporting product remediation • Initiate new or revised documentation • Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies • Lead cross-functional teams to develop risk assessment • Develop physical and functional test methods to ensure specifications are met • Write, review and approve design verification and validation protocols and reports • Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications • Conduct and /or coordinate testing outlined in protocols and test methods • Perform process improvement, control and monitoring on manufacturing processes • Provide technical direction during design transfer activities • Participate and provides input to training on department/division procedures, and policies • Develop and implement procedures to comply with corporate and industry standards • Understand and follow company procedures on regulatory requirements • Provide support to the regulatory department in writing technical submissions • Provide positive example and actively promotes compliance to all standards • Maintain a professional working relationship with internal and external customer and support staff • Prepare and present project updates and technical discussions • Familiar with the latest editions of standards IEC 60601 Series (especially and ), IEC 62304, IEC 62366 & ISO 14971 • Familiar with sampling standards like ANSI/ASQ Z1.4, ISO 2859-1 and ANSI/ASQ Z1.9 • Familiar with reliability references like MIL-HDBK-217F, MIL-HDBK-344A and MIL-HDBK-781A is a plus • Ability to work together with others in a team environment, using data and soft skills to navigate towards solutions Basic Skills/Competencies Required: • Must have a minimum of 3 years' experience with either New Product Development OR Sustaining Products • Strong experience with developing/creating design input requirements (DIRs) and risk management documentation (Design FMEAs) is a PLUS • Medical Device experience is strongly preferred, but not required • Quality Engineering experience desirable, but not mandatory • Ability to make and present engineering decisions • Able to perform PCB/system level design reviews or PCB testing • Demonstrated Project Management skills • Understanding and application of DOE • Ability to analyze and optimize manufacturing and quality systems • Advanced product, design & prototyping skills and perform design review functions • Ability to create, review and coordinate test protocols and reports • Ability to generate engineering proposals • In-depth knowledge of regulatory requirements • Ability to develop and control a budget and understand engineering cost analysis Additional Skills: • Advanced statistics and software application skills • Advanced problem-solving skills • Ability to create/provide training, manage technical personnel and lead cross functional teams • Strong interpersonal skills and must read, write, speak and understand English • Must be detailed in handling information/data and have excellent oral and written presentation skills Education required: • BS in Electrical Engineering (EE) or Computer Science/Systems (CS) or Software Engineering (SE) strongly preferred, or • BS in Engineering (Biomedical, Mechanical, Materials, Chemical), ideally with practical work experience in electrical or software technologies
Created: 2024-10-08