Engr , Quality

Position: Engr 1, Quality
Description:

Quality Engineer II
12 month contract

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 60601-1 and 60601-1-2), 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