🌎
This job posting isn't available in all website languages
📁
Engineering
📅
18000K8U Requisition #
Share this Job

CAREERS THAT CHANGE LIVES


 

The Sr. Supplier Quality Engineering position on the team supports new product development for the Powered, Stapling or Access & Instrumentation platforms. In this role, the Sr. Supplier Quality Engineer works as part of the Quality team supporting the cross-functional Core Team. As a member of Supplier Quality, a key function will be to drive component qualification through effective partnerships with external suppliers, and internal design and development teams, to assure that our products exceed the requirements and expectations of patients, physicians, regulatory agencies and the business.


 

 Impact patient outcomes.  Come for a job, stay for a career


 

A DAY IN THE LIFE


 

POSITION RESPONSIBILITIES:

 

 

  • Understand therapy (clinical) performance, disease states, product function(s), and product use conditions to appropriately and strategically apply supplier selection, development, component qualification and production control plans. 
  • Define supplier objectives and design requirements, partner with suppliers to ensure components are designed for reliability, manufacturability, and cost reduction via component specifications. Ensure supplier feedback is included in the development process.
  • Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.
  • Drive supplier requirements and supplier performance objectives by collaborating effectively with Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs. 
  • Develop commodity strategies with Sourcing team to locate, evaluate, and approve new potential component/material suppliers that balance business, quality, and technical requirements and complete necessary work to approve them as a supplier.  Develop and maintain technology roadmaps with suppliers to enable innovation and integrate future component, manufacturing, and business needs. 
  • Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Resolve components/material failures and focus actions on the root cause.  Assure compliance to procedures and timely completion of CAPAs and audit findings.
  • Ensure compliance to quality system of medical device/combination products development practices.  May develop, modify, or maintain quality system procedures owned by the Supplier Quality organization Develop and maintain expertise in supplier relations and material commodities (e.g. plastics, electronics, metals, chemicals, fabrics, sutures, OEM) product development methods, manufacturing methods, and commodity standards.  May publish papers or present at internal or external conferences.

  • Plan, execute, and communicate own work and educating others on work products. Provide regular, timely communication to manager and project team regarding status of assigned activities.  This may include public speaking, publications, and patent applications.
  • Interpret and contribute towards Engineering Process: design intent, risk management, therapeutic & design functionality, develop qualify & implement controls
  • Supplier Development; establish & sustain effective partnerships with suppliers, develop technical capability
  • Performing other related duties as assigned 
  • Work related travel (Domestic and overseas) 10 – 25 % 
MUST HAVE:  MINIMUM BASIC QUALIFICATIONS
 

EDUCATION REQUIRED: 

 

Specific minimum educational requirement and or equivalent experience/education mix

  • Bachelor’s in Engineering, Science or technical field, or 10+ years of medical device quality experience
 
 

EXPERIENCE REQUIRED:

 
  • 4-7+ Years engineering experience in a manufacturing or quality function and Bachelor’s in Engineering, Science or technical field; or 2+ Years’ experience with an Advanced degree in engineering, science or technical field; or 10+ years of medical device quality

 

KNOWLEDGE AND EXPERIENCE:

  • Medical Device Industry experience

    Six Sigma/ DFSS / Lean Green Belt or Black Belt trained

  • Strong knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE, and other statistical tools related to design, development, and manufacturing

SPECIALIZED KNOWLEDGE REQUIRED: 

 

  • Metrology & Measurement; statistical analysis (Cpk, standard deviation, etc), measurement uncertainty, GD&T, Gauge Repeatability & Reproducibility

  • Quality System Knowledge; Interpret and apply relevant regulations and standards for products and processes (IEC, FDA, ISO etc.)


NICE TO HAVE:  PREFERRED REQUIREMENTS: 

  • Masters in Engineering, science or technical field
  • ASQ CQE, CQA and/or CSQP certification
  • Six Sigma/ DFSS / Lean Green Belt or Black Belt certified
  • Strong communication, organizational and project planning skills
  • Demonstrated track record of effectively influencing and negotiating with suppliers and leading effective/successful change initiatives


 

ABOUT MEDTRONIC:


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. 


We can 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.


EEO STATEMENT:

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:
http://www.uscis.gov/e-verify/employees


DISCLAIMER:


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

North Haven, Connecticut, United States

📁 Engineering

Requisition #: 190000MY

North Haven, Connecticut, United States

📁 Engineering

Requisition #: 18000NMH

North Haven, Connecticut, United States

📁 Engineering

Requisition #: 18000E2Q

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More

Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

Learn More

EMPLOYEE STORY:
ENGINEERING

Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

Learn More

WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

Learn More

We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More
The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.