Senior Quality Engineer-Hardware - ENT
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Careers That Change Lives
A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a Sr Quality Engineer you will
Witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life.
Representative and/or Lead for the New Product Introduction (NPI) Quality team on the NPI Core Team on small to medium size projects.
Compliance oversight over the medical device NPI activities in accordance with the applicable Standard Operating Procedures (SOP's) and External Standards as part of the NPI process.
Contribute and lead activities during the following activities:
Risk analysis, including product risk assessment ownership, key stakeholder to various Failure Mode and Effects Analysis, and assessing specific product issues for impact to patient and/or user safety and product quality
Drawing and specification reviews
Verification and Validation testing and reporting
Product performance reviews
Test method validation
DHF audits
Execute work using an Agile Scrum framework to manage NPI activities.
Engage in a collaborative, diversified and energetic team environment focused on delivering high quality products to our patients and users.
Responsibilities may include the following and other duties may be assigned.
Mechanical drawing review and approval in accordance with ASTM-14.5Y.
Performs 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.
Technical problem solving, compiles data and prepares reports on findings, to identify trends, proposes corrective action as needed.
Collaborates with NPI project cross-functional team to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products equipment.
May specialize in the areas of NPI risk management, test method validation, equipment calibration/qualification/validation.
Travel requirement: Less than 10%
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