Quality Engineer II

Essential Job Functions

• Provide Quality Engineering representation on New Product Development team
• Initiate new or revised documentation
• 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
• Cover 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 provide 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 promote compliance to all standards
• Maintain a professional working relationship with internal and external customers and support staff
• Prepare and present project updates and technical discussions

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
• Able 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
• Able to analyze and optimize manufacturing and quality systems
• Advanced product, design & prototyping skills and perform design review functions
• Able to create, review and coordinate test protocols and reports
• Able to generate engineering proposals
• In-depth knowledge of regulatory requirements
• Able to develop and control a budget and understand engineering cost analysis

Additional Skills

• Advanced statistics and software application skills
• Advanced problem-solving skills
• Able 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