Senior Quality Engineer

Job Duties

• Lead Quality Engineering for the New Product Development Core team developing new technologies for the treatment of various cardiac arrhythmias.
• Responsible for design verification and validation activities for device in development.
• Support the development of design solutions.
• Perform complex tests and analyses to ensure that products are aligned with established specifications.
• Perform statistical analysis of data generated, including but not limited to: process capability, Cpk, Ppk, Gauge R&R, ANOVA, Sample Size determination, and variable/attribute data analysis against predetermined acceptance criteria.
• Compile data and prepare reports on findings, to identify trends and propose corrective action as needed.
• Recommend and implement revisions, corrections, and changes to applicable test equipment, procedures, and methods.
• Troubleshoot defective products during the development and testing phases.
• Perform risk management activities to prevent unforeseen failure modes and improve the capacity of the processes, including FMEAs (Design, Application, Process).
• Utilize output, confidence, and reliability to determine appropriate sample size for product verification testing.
• Create, revise and approve Engineering Change Orders (ECOs) and Change Notices (CNs) on cPDM/Windchill for device/component/sub-assembly specifications, and for work/process instructions in pre-production and at production level.
• Requires up to 20% travel (domestic & international).
• May telecommute 2 days per week.

Requirements

• Employer will accept a Master's degree in Biomedical Engineering or related field and 4 years of experience in the job offered or in a Senior Quality Engineer-related occupation.

Benefits

• This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.