Senior Engineering Supervisor

Must Have: Minimum Qualifications

Responsibilities

• Manages a team of contributors on post market surveillance activities. This includes the investigation tasks of product malfunctions, product design and/or labeling problems, as well as customer dissatisfaction issues, and the regular monitoring and reporting of complaint handling status and metrics. Monitors metrics and drives process improvements based on performance trends.
• Leading the team as a people manager, motivating the team and ensuring through good leadership ensuring defined performance outcomes. This also means influencing and managing change without authority in a matrix organization to achieve the best business results.
• Drive product quality improvements and support quality-based processes to ensure the highest quality of products and solutions as well as compliance with all applicable regulations and requirements.
• Collaborate with business partners to share feedback in order to improve product/process performance.
• Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions as required.
• Ensure quality customer and regulatory communications for current products.
• Manage issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
• Support and participate in internal and external audits, risk management summaries and health hazard evaluations if required.
• Service as a coach/mentor for team members.
• Support goal setting and developmental opportunities for team members
• Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
• Management and strong leadership skills in a challenging working environment with a proven track record of 3+ years of experience in managing and transforming a large team.
• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169;
• Engineering degree in relevant experience.
• 6+ years of related experience in a medical device or regulated industry preferably in combination with Post Market Surveillance and related processes.
• Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Strong interpersonal and communication skills at all levels in the organization, a real people manager.
• Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways
• Strong written and oral communications skills
• High reliability and quality focus
• High engagement, motivation and flexibility
• Self-starter and accountable, with sharp focus on quality and customer experience
• Effective influencing skills, including building rapport with internal customers.

Nice to Have

• Lean Green Belt or Black Belt
• knowledge of appropriate global medical device regulations, requirements, and standards.
• Self-starter and accountable, with sharp focus on quality and customer experience
• Effective influencing skills, including building rapport with internal customers.

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.