Sr Quality Engineer (Onsite)

Careers that Change Lives

We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

In this exciting role as a Senior Quality Engineer, you will have responsibility for supporting the development of components used primarily in implantable medical devices. The Brooklyn Center facility also known as Medtronic Electronics Components Center (MECC) supports the design, development and production of components used in devices for a variety of Medtronic businesses. This role reports to the Operations Quality Director -Components at MECC. Key aspects of this role include leading and/or supporting nonconformance investigations, review and disposition of non-conforming product, collaborating with customer sites (downstream Medtronic facilities) on non-conformance investigation and resolution, supporting continuous improvement/programmatic savings initiatives, and support day to day operations within the Molding Focus Factory.

A Day in the Life

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

• Develops, modifies, applies and maintains quality standards and protocol for processing molded components into partially finished or finished materials product for use in internal manufacturing lines or other Medtronic facilities.

• Collaborates with engineering and manufacturing functions to investigate and resolve quality or compliance issues discovered during manufacturing operations.

• Drive product containment decisions and support physical and electronic product segregation for non-conformances; author and approve associated non-conforming product dispositions.

• Partner with quality engineers in assigned focus factories to ensure compliance with internal and/or external specifications, regulations, and standards such as ISO. Ensures that documentation is compliant with requirements.

• Communicate and escalate significant issues identified during quality activities; recommend process improvements.

• Interface and coordinate with other Medtronic facilities (e.g. downstream customer sites) to resolve issues and implement creative solutions.

• Participate in corrective/preventive action teams in resolving production, customer and supplier issues (e.g., nonconformances, CAPA activities, audit findings)

• Review equipment and process validations, test method validation, process changes, etc., in order to ensure compliance and assess the impact on product quality/reliability and process capability.

• Applies and maintains quality standards and procedures.

Must Have: Minimum Requirements

• Bachelors degree required

• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

• Working knowledge of ISO 13485, ISO 14971, 21CFR820

• Knowledge of Injection Molding (1st and 2nd Shot) and Process Assembling of Molded Components

• Knowledge of Process Validation (IQ/OQ/PQ), TMVs, PFMEAs, Control Plans, Capability Analysis, Tooling Inspections

• Knowledge of DMAIC / Lean Six Sigma principles

• Good statistical data analysis skills

• Excellent verbal and written communication skills

• Ability to interface with internal customers and suppliers

• High attention to detail and accuracy

About Medtronic

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location,