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Sr. Design Quality Engineer
3 months ago
In this exciting role as a Senior Design Quality Engineer – Process Development in the Pre-Market Hardware Quality organization, you will serve as a subject matter expert by leading and providing process development quality support for the new product development programs ranging across electromechanical device manufacturing and sensor fabrication processes.
The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements including hardware/system work products to ensure compliance.
This individual will ensure that all system-level project / program work products as it pertains to risk management and process development / validations (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic's quality, reliability, and compliance requirements.
The ideal candidate has a strong background in process design, development and qualification including Test Method Validation (TMV) and design transfer.
This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R).This position will work across the organization driving and collaborating with functions in Design & Development, Operations, Quality and Regulatory to assure the successful execution of business goals.
DIABETES
The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community.
As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it.
We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier.
Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
Visit to see an overview of the products in our Diabetes product portfolio.A Day in the Life
Drive risk management deliverables by facilitating and generating process failure modes effects analysis (PFMEA) and Hazard Analysis and experienced in facilitation / execution of the process FMEAs
Lead process development activities for large and complex medical device product development programs by effective utilization of PFMEA structure to identify key process inputs, outputs, control as well noise factors
Collaborate with product and process development teams to develop P-diagram/ Input-Process- Output (IPO) matrices, process characterizations, test methods and process validation strategies (IQs/OQs/PQs and TMVs) for new products in development
Ensure essential design outputs / critical to quality (CTQ) attributes are traced down to manufacturing process output specifications and controlled in manufacturing processes by partnering with appropriate design and operations team members in early design and development
Generate master validation plans/reports and design transfer activities as applicable
Play a hands-on role in design transfer planning and ensure development projects are transitioned to manufacturing facilities – play a key role if defining success KPIs, design specifications to process output specification flow down, manufacturing process development & qualification for transitioning development projects to manufacturing across multiple Medtronic sites and quality systems.
Apply methodologies such as Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA) and Cell Operating System (COS) during process design and development phase
Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, GR&R etc.
Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities.
Understands the interdependencies of FDA design controls and production and process controls and ensure processes are developed with the right level of control and maturity to deliver products for design verification testing and design validation studies
Design Verification/Validation and Reliability demonstration – Understands and applies basic Design Verification/Validation methods & principles for developing design verification, validation, and reliability test strategies.
Collaborate with the various product development teams like R&D, Ops, Design / Supplier quality, risk management etc. to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards and regulations
Participates on project teams and technical review boards and leads change control evaluations. Coordinate's quality decisions between different quality and engineering groups.
Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.
Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different operating unit (OU) strategies and products.
Participating in support of external and internal regulatory audits and inspections.
Driving operating procedures / process improvement activities.
Performs other related duties as assigned.
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 or Science with 4+ years of work experience in Quality and/or Development
OR
Master's Degree in Engineering or Science with 2+ years of work experience in Quality and/or Development.
Nice to Have
Experience working in a regulated industry (e.g., FDA-regulated).
Master's Degree in Engineering, Quality, Regulatory, or related.
ASQ-CQE, CSSGB, CSSBB or equivalent certifications
Hands on experience in process development for electromechanical devices, sensor fabrication
Strong understanding and hands on experience with the FDA production and process controls (P&PC), experience in planning of process validation / test method validation activities
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, GHTF guidance on process validations
Formal training in Six Sigma or DRM Greenbelt or Blackbelt
Ability to author technical reports, business correspondence and standard operating procedures.
Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.
Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
Self-Starter with a sharp focus on quality and customer experience.
About Medtronic
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.
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.
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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
(ADA-United States of America)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.
Learn more about our benefits here ) .This position is eligible for a short-term incentive plan. _ _ Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
The provided base salary range is used nationally (except in certain CA locations).
_ _ The rate offered is compliant with federal/local regulations and may vary by experience, _ _ certification/education, market conditions, location, etc.
Min Salary98400
Max Salary
147600
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.
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