We anticipate the application window for this opening will close on - 14 May 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

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

The Medtronic Grand Rapids site offers a Principal Quality Engineer level role in the Operations Quality group. This role is for an experienced engineer looking to make an impact on the site and positively affecting patient’s lives. This fast-paced role includes partnering with Operations, Manufacturing Engineering, Supplier Quality, Safety (and more) to drive improvements and risk reduction. The Grand Rapids site manufactures Cardiac Surgery devices sold across the globe. Come make a difference!

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

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

• Provide product containment decisions for non-conformances; author and approve associated non-conforming product dispositions.

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

• Ensure assigned value stream is compliant with internal and/or external specifications, regulations and standards such as ISO.

• Lead and/or participate in statistical process control initiative and establishing a Key Point Indicator monitoring plan for manufacturing processes

• Lead and/or participate in Continuous Improvement activities such as First Time Quality (FTQ), Nonconformance reduction to address quality instabilities in support of Cell Operating System

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

• Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.

• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

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

• Support internal and external site audits and inspections.

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

• Develop, modify, apply, and maintain quality standards and procedures.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. 

• 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

Nice to Have

• Operations Quality experience 5+ years

• Experience managing or mentoring engineers

• Risk Management or CAPA experience

• Excellent verbal and written communication skills

• Ability to interface with internal customers, suppliers and external regulatory agencies

• High attention to detail and accuracy

• Medical device experience strongly preferred

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 mad