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
Medtronic Diabetes helps people gain better control and awareness over their diabetes. We work in the challenging space where medical devices are in the hands of everyday people, and those people expect state-of-the-art technology to help make managing their diabetes easier and more connected.
In this exciting role as an Engineering Manager, you will have responsibility for managing a team of hardware and process engineers involved in the development and commercialization of the new products for the Diabetes Group. In addition, you will act as a Quality Core Team Member, being the focal point of Quality for Medtronic product and system development programs in the Diabetes business. You will be a core team member leading and representing the Quality function to reach the highest level of quality and clinical outcomes for these products. In this role, you will represent the voice of quality by providing technical expertise to the Product Development activities and driving efficiency to the processes through various process improvements. This role will plan all quality deliverables, activities, resources, application of a rigorous approach in design, manufacturability, and reliability, and be the voice of quality throughout the development lifecycle.
Responsibilities may include the following and other duties may be assigned:
- Provide direct supervision, coaching and mentoring to the design and process development quality engineers in your team.
- Plans, directs and implements quality related aspects of the company's design and development of new products within the portfolio.
- May develop, evaluate, implement and maintain technical quality assurance and control systems and standards.
- Serves as a primary focal point and contact for all quality aspects of a project.
- Maintains alignment and manages execution across all Global Quality disciplines.
- Collaborate with R&D, system engineering, our product management organization and partner engineering teams.
- Drive establishment of Quality, Reliability, and product development strategies.
- Provide leadership and guidance to create consistency in our architecture, interface, and designs.
- Drive development of test strategies for complex systems.
- 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.
- Monitors documentation maintenance throughout all phases of research and development.
- Regularly interacts with site leadership.
- Selects, develops and evaluates personnel to ensure efficient operation.
- Training and coaching cross-functional peers on maintaining compliance.
- Lead external and internal regulatory audits and inspections.
Must Have: Minimum Requirements
Bachelors Degree in Engineering or Science field with 5+ years of experience in quality and/or engineering with 3+ years of managerial experience OR Masters Degree in Engineering or Science field with 3+ years of experience in quality and/or engineering with 3+ years of managerial experience.
Nice to Have
- Experience working in a regulated industry (e.g., FDA-regulated).
- Master’s Degree in Engineering, Quality, Regulatory, or related.
- Working knowledge of electromechanical medical devices.
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD & EU MDR.
- Experience in Design-Reliability-Manufacturing (DRM).
- Experience with leading large, complex initiatives of strategic importance.
- Project experience in hardware testing practices, methodologies, and techniques.
- Ability to author technical reports, business correspondence and standard operating procedures.
- Ability to apply knowledge and work with development and supply vendors.
- FDA regulatory experience.
- Strong verbal and written English communication skills.
- Ability to multi-task, prioritize, meets/exceed deadlines.
- Self-Starter with a sharp focus on quality and customer experience.
- Certifications in Quality Engineering, Quality Management or Program Management.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD): $136,000.00 - $204,000.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity.
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