Sr. Hardware Design Quality Assurance Engineer- Combination Devices
Sr. Hardware Design Quality Assurance Engineer- Combination Devices
Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.
Apply remote type Hybrid locations Los Angeles, California, United States of America time type Full time posted on Posted 5 Days Ago job requisition id R6008
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
In this exciting role as a Senior Design Assurance Engineer Combination Products in the Pre-Market Hardware Quality organization, you will serve as a subject matter expert by leading and providing technical design quality support for the new drug / device combination product development programs.
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 (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements.
A Day in the Life
Leading large and complex drug / device combination product development programs per the FDA design controls starting from design planning through design transfer.
Collaborate with systems engineering and product development teams to develop and evaluate designs.
Drive risk management deliverables by facilitating and generating design and process failure modes effects analysis (DFMEA / PFMEA).
Utilize risk management principles to lead development and identification of essential design outputs.
Partner with cross-functional counterparts to strategize and support combination product stability evaluations.
Collaborating with various product development teams to ensure work products comply with Medtronic procedures.
Play a hands-on role in design transfer planning and ensure development projects are transitioned to manufacturing facilities.
Generating master validation plans / reports and design transfer activities as applicable.
Use statistical techniques or data analysis to inform design decision making.
Assisting Supplier Quality engineering and purchasing teams in vendor development.
Understanding the interdependencies of program work products and guide the teams in execution strategy.
Participates on project teams and technical review boards and leads change control evaluations.
Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements.
Driving clarity and consistency in documentation.
Leading CAPA projects and assisting post market analysis.
Participating in support of external and internal regulatory audits and inspections.
Driving Process improvement activities.
Develops, modifies, applies, and maintains quality standards and protocol for processing materials.
Devises and implements methods and procedures for inspecting, testing, and evaluating products.
Ensures that corrective measures meet acceptable reliability standards.
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 Engineering OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and / or Engineering.
Nice to Have
Experience working in a regulated industry (e.g., FDA-regulated).
Bachelor’s Degree in Biomedical, Mechanical, Chemical or Electrical preferred.
Master’s Degree in Engineering, Quality, Regulatory, or related.
ASQ Certification in Quality or Reliability.
Strong understanding and hands-on experience with FDA production and process controls.
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
Understanding of the interdependencies of program work products.
Experience with planning and executing design verification testing.
Working knowledge of hardware development for medical devices.
Ability to author technical reports and standard operating procedures.
Strong verbal and written English communication skills.
Ability to multi-task, prioritize, and meet deadlines.
Self-Starter with a sharp focus on quality and customer experience.
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.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package.
Salary ranges for U.S (excl. PR) locations (USD) : $94,400.00 - $141,600.00.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
Medtronic benefits and compensation plans.
About Medtronic
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 90,000+ passionate people.
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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