About the Role

Join MiniMed as a Sr Quality Engineer I and play a hands-on role in keeping our medical device manufacturing operations compliant, efficient, and patient-focused. You'll tackle nonconformances, drive investigations, support document control, and partner cross-functionally to resolve issues at the source - all in a regulated environment where quality truly matters.

Responsibilities may include the following and other duties may be assigned.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• 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.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• 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.

Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Requires Engineering Bachelor Degree
• Requires minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience..

Nice to Have:

Experience with Risk management documentation: pFMEAs
• Basic knowledge in statistics (preferably using Minitab)
• Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing)
• Engineering degree: Mechanical, Electrical or Chemical preferred
• Experience investigating manufacturing operations events in support for product disposition
• Experience assessing and tracing manufacturing defects/rejects trends
• Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory)
• Knowledge in Medical Devices regulations
• Experience with projects: design requirements validation, manufacturing controls

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package