Job Description: Summary
This position provides risk management support to new product development teams ensuring that transferred designs and the associated manufacturing processes are reliable.
The successful candidate will be familiar with disposable and reusable products, and be able to demonstrate knowledge of risk management tools (e.g., FMEAs, FTAs), statistical analysis, test method validations, root cause analysis, and a fundamental understanding of Quality System Regulations and good documentation practices.
Essential Job Functions:
Provide Quality Engineering representation on Product Development Teams.
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.
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.
Conduct complaint investigations.
Participate and provides input to training on department/division procedures, and policies.
Coordinate and lead internal and supplier audits.
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.
Strong working knowledge of the latest editions of standards IEC 60601 Series (especially 60601-1 and 60601-1-2), IEC 62304, IEC 62366 & ISO 14971.
Working knowledge of 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: BS in Electrical Engineering or Computer Science strongly preferred or BS in Engineering/Science with Minor in Electrical Engineering or Computer Science
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
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
Primary Work Location
USA AZ - Tempe BPV Building 3
BD (Becton, Dickinson And Company)