At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain restore health and extend life for millions of people worldwide.
In this exciting role as a Principal Supplier Quality Engineer you will have responsibility for management of supplier transfers within the Global Supplier Quality Supplier Change Implementation Team. You will have responsibility for and authority to provide Quality Assurance Engineering representation to select business teams facilitating front-end design design transfer to manufacturing and process improvements to obtain optimum product reliability safety and effectiveness. Coordinate feedback of quality indicators and statistics to business team for use in business decisions. Perform direct or consult in supplier validations. QA approvals for Engineering Change Notices test methods and test equipment to assure the design and production of medical devices are in compliance with applicable standards.
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a trusted partner means always putting patient safety first upholding product quality and maintaining the highest ethical standards in our business relationships and programs.
Responsibilities may include the following and other duties may be assigned.
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.
Execute Product Qualification activities ensuring suppliers are capable of delivering quality products and materials.
Provide technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.
Execute Product Acceptance Strategy and associated test method validation at suppliers.
Evaluate suppliers internal functions to assess their overall performance and provides feedback in assessment of their operation.
Develop and deliver the Product Acceptance Sampling Strategy Approved Supplier List coordination and Supplier Owned Quality deployment for transferred products.
Must Have: Minimum Requirements:
To be considered for this role please ensure the minimum requirements are evident on your resume.
Requires a Bachelors degreein Engineering Science or Technical field and minimum of 7 years of relevant experience OR Masters degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.
Nice to Have
Requires mastery level knowledge of specialty area and working knowledge of several other areas typically obtained through advanced education combined with experience. May have deep knowledge of project management.
Supplier Controls process knowledge and experience including creation and maintenance of supplier files in the approved supplier list (ASL)
Experience in Windchill and Agile PLM systems
Working knowledge of FDA regulations and ISO standards applicable to implantable and non-implantable medical devices
ASQ CQE CQA and/or CSQP certification
First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified
Knowledge with PPAP process and part/product validation and qualification
Strong knowledge of metrology & measurement techniques; statistical analysis (e.g. Ppk/Cpk standard deviation correlation) in Minitab measurement uncertainty GD&T Gauge Repeatability & Reproducibility
Demonstrated track record of effectively influencing and negotiating with suppliers and leading effective/successful change initiatives
Skilled in project leadership practices including ability to balance risk and benefit effectively influence diverse teams and ownership of responsibility for outcomes.
Excellent downward lateral and upward communication skills
Strong organizational and presentation skills
Good balance of high level strategic and detailed tactical thought processes
Strong competencies in judgment and problem solving (especially root cause analysis)
Travel:
In this role periodic travel is expected to suppliers or other Medtronic facilities. Travel is less than 25%.
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 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Medtronic offers a competitive Salary and flexible Benefits Package
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Staff IC
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 excit ... View more