Senior Pre-Market Quality Engineer
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
Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.
The Brooklyn Center facility also known as Medtronic Electronics Components Center (MECC) supports the production of components used in devices for a variety of Medtronic Operating Units (OUs). This role reports to the Operations Quality Manager at MECC. Key aspects of this role include being a Quality team member on multiple new product development projects as well as existing manufacturing lines, collaborating with customer sites (downstream Medtronic facilities), participating in a culture of collaboration and compliance in one of the Components Focus Factory (Includes Connectors/Molding, Capacitors, TDCO, and Feedthroughs), execute day to day operations, and execute continuous improvement to reduce the overall quality risk within a specific Focus Factory.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Pre-market quality engineering work for the components focus factory.
Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
Drive nonconformance investigation, ensuring proper bounding and containment of product and escalation for Corrective and Preventive Action, as needed.
Drive preventive quality tools, such as First Time Quality, Quality First Reviews, and Operations Quality Walk Gembas, to reduce the level of risk to the product and patient.
Manage the process risk management records to drive risk mitigations as required
Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
Nice to Have
CAPA (Corrective Action / Preventive Action) experience
Familiarity with Minitab Statistical Software
Lean Six Sigma training, DRM Training
Experience working in a fast-paced manufacturing environment
Validation Experience (IQ, OQ, TMV, PQ)
Experience with Batteries
High level of attention to detail and well organized to manage multi
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