Design Assurance Engineering Manager
Req Number - 21000LLM
Santa Rosa, CA or Remote within CaliforniaCareers That Change Lives
The Design Assurance Engineering Management position is primarily responsible for overseeing product development activities for Peripheral Vascular products in a global marketplace. This position may also lead or support Quality functional initiatives as well as Quality System improvement activities. This position is accountable for delivering high reliability and quality products through efficient execution of product development activities and meeting quality objectives/metrics for the business. This position is also responsible for ensuring that the product development activities are in compliance with all applicable internal, corporate, and regulatory standards or requirements.
This position will involve staffing, developing, and resource planning for Design Assurance Engineers, and technicians. Additionally, this role may serve as a Quality Core Team member on new product development efforts.Peripheral Vascular Health
Peripheral and Endovenous therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.A Day in the Life
Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Provide design assurance leadership to the team to assure customer needs and regulatory requirements are met. Ability to look at the larger picture of the development project and influence the Core Team to assure quality objectives are met.
- Provide direction for quality staff (i.e. engineers and technicians) to define design inputs/outputs, conduct design verification and validation, complete risk management, and support process development.
- Build a strong quality engineering team by hiring qualified candidates, establishing and actively managing performance expectations, and providing training opportunities to direct staff. Serve as a coach/mentor for cross-site Design/Quality Assurance Engineers and Technicians
- Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
- Responsible for forecasting department headcount and justification/rational of headcount allocation. Recruit and hire quality staff.
- Demonstrate high technical skills; apply sound engineering judgment, technical writing skills, statistical skills, and critical thinking in product development activities and resolution of quality issues. Creatively and effectively challenges status quo when developing and recommending solutions.
- Provide Root cause investigation and corrective/preventive action support or ownership
- Oversees the investigation and evaluation of existing technologies.
- Directs the development of new concepts from initial design to market release.
- Manages feasibility studies of the design to determine if capable of functioning as intended.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Bachelor's Degree in Engineering, Science, or technical field with 5 + years of experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science, or technical field with 3 + years of experience in Quality and/or EngineeringNice to Have
- Prior experience managing, directing and developing people or projects
- 3+ years of experience with 21CFR Part 820 and ISO 13485 and Quality system requirements in other geographies
- 3+ years of experience with relative ISO and FDA regulations and Good Manufacturing Practices (GMP)
- 3+ years of experience with medical device product development, design verification/validation, risk management, reliability engineering, process validation and Quality systems
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 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. (ADA-United States of America)
Travel up to 25%