We anticipate the application window for this opening will close on - 27 Jan 2025

 

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

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 Sr. Quality Engineer, 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.

 

As the Sr. Quality Engineer, 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.

Must Have: Minimum Requirements

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 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

• Medical Device

• Master’s degree

• Manufacturing Experience

• Green Belt Six Sigma/DRM Training/Certification

• 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

 

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 per