experience: 8 - 10 years Job Description Careers that Change Lives A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. In this exciting role as a Sr Engineering Program Manager you will have responsibility for project management and leadership for the escalation and resolution of issues associated with the performance of Pelvic Health released products. A Day in the Life Responsibilities may include the following and other duties may be assigned. - Responsible for released product performance issue escalation, reporting and resolution including critical product quality and segregation decisions based on known information. Champion excellence for released product quality and reliability and patient safety. - Lead cross functional project teams for issue investigation analysis and resolution process to meet regulatory requirements and business goals, which may include global field corrective actions. Members may include Design, Medical Safety, Manufacturing, Supply Chain, Quality, Reliability, Regulatory and Marketing functions. - Exercise sound judgment within defined practices and policies, including CAPA policies and procedures. - Accountable for all aspects of work product including written documentation, interpretation and use of policies, procedures, regulations, and standards. - Responsible for developing, communicating, and documenting investigation plans associated with Nonconformances, complaint investigation and Fielded Product Action processes. - Strong written and verbal communication skills. Able to prepare timely concise, unambiguous, fact-based summaries and decision rationales, suitable for review by inspectors and regulators - Facilitate good cross-functional and cross project team communication, collaboration, and coordination to ensure successful completion of issue investigation and resolution. - Applies knowledge of Quality System, standards, and regulations to plan and manage quality solutions on a global basis. - Proficient use and demonstrated application of advanced Quality Tools and facilitates coaching and training on application of tools, such as Basic Six Sigma, DOE, Advanced Statistical Techniques, QFD, Weibull, Business Objects, or GCH. - 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. - 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 To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor’s Degree with 7+ years of work experience in Quality and/or experience in a regulated industry plus 5+ years of leadership experience OR Advanced Degree with 5+ of work experience in Quality and/or experience in a regulated industry plus 5+ years of leadership experience. Nice to Have - Experience working with health software including software deployment and control - Well-developed critical thought process, able to analyze technical detail and provide solution process. - Proficient in word processing, spreadsheets, presentation, and project management tools. - Highly developed skill set in project leadership practices, including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes. Excellent downward, lateral, and upward communication skills. - Good balance of high level strategic and detailed tactical thought processes. - Demonstrated track record of successfully leading projects to completion under tight time constraints. - Skilled at facilitation, consensus building and conflict resolution with peers. - Strong competencies in judgment and problem solving. - Working knowledge of multiple quality disciplines, especially reliability, safety, and compliance. - Quality or reliability engineering experience in product development or high-volume manufacturing. - Experienced practitioner of Design for Reliability and Manufacturability (DRM) - Knowledge and experience with Lean Sigma tools. - Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations. - FDA audit support experience. - Has working experience with reliability tools, including failure mode and effect analysis, statistical analysis, risk analysis, inspection test method validation and design test verification and validation. 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)
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