Your dedication is important to our customers and, most importantly, to their patients.
Medtronic is currently seeking a Sr Design Quality Engineer.
Provide Quality Engineering support and leadership to ensure the successful development of Medtronic Neurovascular products and ongoing operational support. This individual will be expected to apply his/her knowledge of Design Control principles and quality engineering techniques to positively influence product development efforts. In parallel, the candidate shall also ensure the products are developed and manufactured in accordance with applicable company policy, industry standards, and regulatory requirements.
Do meaningful work, make a difference, and improve lives — starting with your own.
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
A Day in the Life
• Actively represent Quality Assurance function on product/process development teams. • Mentor less senior Quality Engineers and quality technicians. • Provide guidance to Engineering staff and other personnel and ensures that Design Control requirements are being met in an effective manner, including Design Input/Output, Design Verification/Validation, Risk Management, Test Method Validation, Component Qualification, and Process Validation. • Lead the investigation of complex technical issues. • Hands on participant in early stages of product development including but not limited to physician interaction, competitive product testing, and prototype testing. • Identifies and manages risk throughout the development process with the use of FMECA and/or other risk management tools. • Develops master test plans that encompass Design Verification/Validation, and Process Validation activities. • Review and approval of protocols and reports to ensure that the testing is technically sound and sufficient to meet internal/external requirements and overall project quality objectives. • Review and approval of design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products and processes are capable of producing products that are safe and effective and in full compliance to company policies and procedures. • Contributes to VOC/VOB activities. • Promotes a continuous improvement culture in Design Control activities and proactive utilization of quality tools with design team. • Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Medtronic Neurovascular specifications. • Creates validation plans for components, subassemblies, and finished devices.
Responsibilities may include the following and other duties may be assigned.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies 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.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
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.
Must Have: Minimum Requirements
EDUCATION REQUIRED: • Bachelor’s Degree in Engineering or Science
YEARS OF EXPERIENCE • 4+ years of experience with a Bachelor’s degree • 2+ years of experience with a Master’s degree
Nice to Have
• Prior experience in the Medical Device industry in design and development of Medical Devices. • Experience with vascular devices, embolic coils, stents, catheters, balloons, and aspiration devices • Self-motivated and committed to a team approach • Ability to conduct hands-on technical work • ‘Can Do’ attitude with continuous improvement mindset • Strong interpersonal, organizational and project management skills • Strong oral, presentation and technical writing skills • Demonstrated proficiency in decision making – preferably across a broad spectrum of Quality Engineering responsibilities • Extensive knowledge and application of quality tools: o Risk Analysis o Statistics o Six sigma o DOE o LEAN o Problem Solving Technique • ASQ Certification
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 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 Day in the Life 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 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