Quality Engineer II
A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a Quality Engineer II, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.
This is an onsite role at the Danvers, MA location.
A Day in the Life
As the Quality Engineer II, you will:
- Provide Quality Engineering support for commercial medical device products.
- 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.
- 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; 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.
- 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.
- Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
- Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
- Present technical data to groups within and outside the organization.
- Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.
Nice to Have
- Medical Device
- Master’s degree
- Manufacturing Experience
- Green Belt Six Sigma/DRM Training/Certification
- Plastics engineering experience
- ASQ-CQE, CQA, CBA or equivalent certifications
- SAP QM or SPC Software Experience
- Effective verbal and written communication, analytical, influencing and interpersonal skills
- Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016
- Demonstrated working knowledge of process validation, statistical methods, risk management
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 in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
