The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
A Day in the Life
- Manages the activities of the Metrology Department with responsibility for results in terms of costs, methods, and employees. Accomplishes results through Lab Managers and Supervisors and through experienced exempt employees to achieve operational plans and goals. Provides primary decisions on hiring, promotions, performances, rewards, and discipline decisions for direct reports and advises on all indirect reports. Recommends organizational structures of metrology and equipment services functions.
- Frequent contacts with equivalent level managers and customer representatives concerning projects, operational decisions, scheduling requirements, or contractual clarifications. Conducts briefings and technical meetings for internal and external representatives. Exerts influence in the development of overall objectives and long-range goals of the organization.
- Collaborate with customers and key stake holders to develop a strategy necessary to drive initiative to improve quality and compliance and improve operational cost.
- Provide the required leadership to keep employees motivated to achieve their best. Invest time and focus on efforts to develop high performing team through mentoring and coaching. Leads and supports initiatives to drive a diverse and engaged organization.
- Maintain a safe work environment for all employees, customers, and processes.
- Achieve a high level of service that will control costs, support cycle time, and maintain the quality, operation, integrity, and traceability of measurement equipment while meeting regulatory requirements.
- Identify, report, and effectively resolve quality issues. Prepare for and support internal and external quality audits of metrology operations and equipment. Be a subject matter expert with ability to effectively communicate with internal and external auditors and investigator.
- Communicates and gains cooperation with internal customers and external suppliers by sharing and exchanging relevant information to reach solutions concerning operations or scheduling of specific phases of projects.
- Plan capital and expense budget to meet annual business target. Manages day-to-day elements of the budget and report variances and plan adjustments where needed.
- Establish, monitor, and report laboratory metrics to meet department and business goals. Ensure that projects are completed on schedule and within budget.
- Support leadership to meet on-going business requirements. Acts as an advisor to staff members to meet schedules or resolve technical or operational problems.
- Develop, implement, and review operating processes and equipment procedures to ensure continuous compliance to business and regulatory requirements. Recommend modifications to business level operating policies.
- Stay current on industry best practices to continuously improve laboratory operations. Develop knowledge retention and training program to ensure employees have the appropriate skills and capabilities to perform at a high level.
- Lead/support internal collaboration of calibration and equipment service sites across Medtronic to promote the exchange of ideas and methodologies in such a way as to leverage our diverse technical skills and quality processes to the distinct benefit of the Corporation, Clients, and our own operations.
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.
Nice to Have
- Medical device industry experience.
Project Management experience.
5+ years of manager experience in a high-tech manufacturing/quality environment providing direct measurement and process equipment support.
Previous experience working directly with a metrology/calibration department and/or engineering department managing measurement standards or precision measurement systems. Basic knowledge of measurement principles: measurement uncertainty, measurement traceability, measurement standards, test uncertainty ratios, measurement system analysis (MSA), SI units, calibration intervals, and out-of-tolerance reporting.
- Understands basic management approaches such as project management, prioritizing, process execution, leadership, and coaching. Ability to lead and work well with a diverse group of people in a team environment.
Effective problem solving, exceptional critical thinking, and root cause analytical skills.
Working knowledge of Lean Practices; e.g. 5S, Value Stream Mapping, Six Sigma, DMAIC, Statistical Process Control, Control Charts, or Design Of Experiments.
Working knowledge with ISO 17025, FDA, and ISO regulatory requirements.
Budgeting and resource planning.
Developing business and laboratory metrics.
Formal training and experience calibrating measurement equipment and standards. Expert knowledge of measurement principles: measurement uncertainty, measurement traceability, measurement standards, test uncertainty ratios, SI units, calibration intervals, and out-of-tolerance reporting.
Expert knowledge with these regulations: FDA 21 CFR Part 820 and 210, ISO 13485, and ISO 17025.
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
- Environmental Exposures:
- Clean Room
- Eye Protection
- Bend/Stoop/Kneel/Lift – 0.5 hour a day
- Stand/Sit/Walk – 7.5 hours a day
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)