Engineering Program Manager (Post Market Quality) - NV - Irvine, CA (Onsite)
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
For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day.
Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Learn more about Neuro Vascular OU here.
#Neuroscience
Careers That Change Lives
In this dynamic position as Engineering Program Manager, you will play a key role in enhancing patient outcomes by driving the timely resolution of post-market quality and product safety concerns. You will lead engineering evaluations of field-reported complaints, analyzing trends related to patient impact, device performance issues, root cause investigations, and ongoing risk assessments through the use of data analytics and signal detection. Supporting the entire Neurovascular product portfolio, you will leverage your expertise in Design Control, Risk Management, quality engineering methodologies, statistics, and data analysis to ensure product safety and regulatory compliance. This role also involves close collaboration with cross-functional Neurovascular teams to implement appropriate product controls based on risk assessments.
Responsibilities may include the following and other duties may be assigned.
Issue Escalation and Evaluation:
Drive the timely evaluation and resolution of post-market product quality and safety issues to ensure patient safety and optimal care.
Lead or facilitate investigations into complex technical problems, collaborating closely with cross-functional teams including Manufacturing, Regulatory Affairs, R&D, and Supplier Quality to determine and implement appropriate actions.
Assess the impact of identified issues through in-depth complaint investigations, health hazard analyses, product holds, and field corrective actions.
Risk Management:
Apply risk management tools to identify, assess, and mitigate risks throughout the entire product lifecycle.
Review and evaluate testing protocols and reports to ensure compliance with regulatory requirements and alignment with quality goals.
Stay up to date on current regulatory standards and requirements relevant to medical device development and commercialization.
Ensure adherence to FDA regulations, international standards, and Medtronic Neurovascular quality procedures.
Utilize large datasets effectively through data mining and analysis techniques to support robust risk assessments.
Maintain deep knowledge of all Neurovascular products and their clinical applications.
Location: Irvine, CA or Mounds View, MN (Onsite)
Ability to travel up to: 25%
Must Have (Minimum Requirements)
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s degree required with a minimum of 5 years of relevant experience
OR advance degree with a minimum of 3 years of relevant experience
Nice to Have (Preferred Qualifications)
Degree in Engineering, Science or Technical discipline is preferred
Proven ability to make sound decisions across diverse Quality Engineering functions
Proficient in project management principles and tools (e.g., Microsoft Project)
Knowledge of Good Manufacturing Practices (GMP) a
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