Principal Quality Engineer- Standard Compliance - Open to U.S. Remote at Medtronic in Northridge, California

Job Description:

Careers that Change Lives

In this exciting role as a Pr. Quality Engineer-Standard Compliance, you will have responsibility for medical device international standards compliance activities to ensure the compliance, safety and reliability of Medtronic Diabetes products throughout the lifecycle of the product (from concept to end of life). In addition, you will be supporting the development of state of art, Medtronic Diabetes Standards Engineering program and systems for both pre-market and post-market.

Diabetes

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

A Day in the Life

• Develops, modifies, applies and maintains quality standards records and protocol for new and sustaining products.
• 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.
• Supports cross functional teams in conducting Standards Engineering activities, including conducting initial evaluations and updates to standards compliance activities.
• Facilitates development of thorough, accurate and practical standards engineering activities by working closely with other cross-functional teams.
• Assesses new and legacy product compliance status for Medtronic Diabetes products to determine if changes to standards compliance have occurred and initiate and coordinate standards compliance activities as required.
• Tracks and monitors new or changing standards and present gap analyses to senior management.
• Facilitates the development of tools, processes and systems to enable a sustainable and substantially compliant standards compliance process.

Must Have: Minimum Requirements

• Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality

• Working knowledge of ISO quality system (ISO13485), US FDA Quality System Regulation (CFR 820), EU Medical Device Directive and EU Medical Device Regulation or equivalent and relevant international standards.
• Knowledge of IEC 60601 series of technical standards and CB certification scheme.
• Hands on experience in standards compliance tools and methodologies, including compliance gap assessments, checklists and essential requirements matrices.
• Experience in developing system and product requirements based on needs from standards and regulatory compliance areas
• Masters of Science Degree in an Engineering or Science-related field.
• More than 5 years' related experience in Quality Assurance and/or Quality Engineering in a regulated environment.
• Experience within the medical device industry.
• Ability to write technical reports, business correspondence, technical procedures as well as administrative procedures that are clear and usable to maintain substantial compliance.
• Good understanding of medical device product development processes
• Self-starter and accountable, with sharp focus on quality and customer experience
• Effective influencing skills, including building rapport with internal customers.
• Ability to represent the department in frequent intra and inter-organizational events
• Ability to provide solutions to difficult technical issues associated with specific projects.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

Additional Information

• Posting Date: Jan 18, 2022
• Travel: Yes, < 25 % of the Time