Sr Design Assurance Engineering Manager (Finance)
Careers that Change Lives
The Senior Design Assurance Engineering (DAE) Manager is a leadership position responsible for driving world-class quality and reliability through the product development process (PDP).
The primary focus of this position is on the Pre-Market or Product Development side of the business with a strong emphasis on design assurance for the design and development, transfer and commercial release of new products. This position also provides engineering support to significant product or process changes, iterations, failure investigations, CAPA processes, and resolution of quality issues. This position will provide overall quality engineering strategy and objectives for the new product development projects as well as process improvements to the quality management systems and ensure all product releases meet all required standards, internal, corporate, domestic and international requirements. This position will involve staffing, coaching, budgeting and allocating Design Assurance and Quality Engineers as well as technicians.
Peripheral and Endovenous
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.
Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities - and grow as we grow.
A Day in the Life
Together with Research & Development, create/manage a technically rigorous and efficient pre-market quality system that consistently enables product performance risks to be identified, characterized, and mitigated to meet or exceed stakeholder and project requirements. Includes the following elements:
- Functional manager for a team of engineers and technicians
- Manage DAE resource allocation in support of PDP programs
- Manage career developmental needs of team in order to meet individuals and organizational objectives
- Provide timely and constructive feedback on job performance
- Identify and hire talent to meet short- and long-term organizational objectives
- Implementation of risk management process and tools
- Compliance to worldwide quality system design control and risk management requirements
- Drive Design for Reliability and Manufacturability (DRM) principles/process within the DAE team
- Support for regulatory submission preparation, internal QC & review and agency question responses
- Support for post-market risk management
- Create and manage AOP for the local DAE function
- Determines organizational structure and establishes operating policies in alignment with the Business Unit needs and CVG Quality function.
- Active member of the CAPA board
- Periodically serve as an independent reviewer for PDP programs
- Manage all DAE PDP deliverables through partnering with cross-functional and intra-Quality management teams (R&D, PMO, Process Development, Regulatory, Component Engineering, Microbiology, Sterilization, , Validations, Operational Quality, Configuration Management, Audit, and Field Assurance) to ensure roles and responsibilities are well-defined, understood, and structured to enable success. Directly influences development of overall objectives and long-range goals of the organization, and initiates programs or projects based on identified business needs.
Responsibilities may also include the following and other duties may be assigned.
- Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
- May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
- Oversees the investigation and evaluation of existing technologies.
- Guides the conceptualization of new methodologies, materials, machines, processes or products.
- 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.
- Monitors documentation maintenance throughout all phases of research and development.
- Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Must Have: Minimum Requirements
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
Bachelor's Degree in engineering, science or technical field with 7+ years of experience in Engineering and/or Quality wtih 5+ years of people leadership OR Advanced Degree in engineering, science or technical field with 5+ years of experience in Engineering and/or Quality wtih 5+ years of people leadership
Nice to Have:
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. 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% Domestic and International
Additional Information
- Posting Date: Apr 1, 2021
- Travel: Yes, < 25 % of the Time
