Engineering Manager - Hardware Design Quality

Careers that Change Lives

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.

Are you the right candidate for this opportunity Make sure to read the full description below.

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 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.

A Day in The Life

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.

This includes work direction, priority and objective setting, development opportunities, training, and performance management.

Plans, directs and implements quality related aspects of the company's design and development of new products within the portfolio.

Ensures compliance in development processes.

• May develop, evaluate, implement and maintain technical quality assurance and control systems and standards pertaining to materials, techniques, or company products including ensuring a thorough connection between design controls deliverables (from design planning, requirements development, risk management, design verification / validation through design transfer) in the DHF to process validation, production and process controls and content captured in the DHR.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products. Ensures risk management processes are fully integrated into development processes and support production and process controls.
• Directs the development of new concepts from initial design to market release. Drives alignment between pre and post market quality teams, ensuring seamless transfers to production.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Regularly interacts with site leadership. Represents quality as a member of the development staff as well as serving on the quality staff.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.
• 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.
• Lead external and internal regulatory audits and inspections as it pertains to design and development and sustaining.

Must Have : Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile :

• Bachelors Degree in Engineering or Science field with 5+ years of experience in quality and / or engineering management
• Masters Degree in Engineering or Science field with 3+ years of experience in quality and / or engineering management

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 with embedded firmware and systems with mobile and cloud applications
• 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) or equivalent corporate design and / or manufacturing process improvement initiative
• Experience with leading large, complex initiatives of strategic importance to the business unit, involving large cross-functional teams.
• Project experience in hardware testing practices, methodologies, and techniques, particularly in testing medical devices is a plus.
• 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.
• FDA regulatory experience- e.g., presenting during FDA audits, responding to regulatory inquiries, communicating directly with FDA statisticians.
• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
• Ability to multi-task, prioritize, meet / exceed deadlines and hold themselves, and others accountable.
• Self-Starter with a sharp focus on quality and customer experience.
• Certifications in Quality Engineering, Quality Management or Program Management.

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)

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.

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