Engineering Program Manager - Senior
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Must Have: Minimum Requirements
•Bachelor's degree in a relevant technical discipline. Examples: Mechanical, Electrical, Software or Biomedical Engineering
•8 + years of experience managing R&D activities and teams
•6+ years of experience of progressive leadership experience or Advanced Degree
•Experience with engineering of Medical Device Development (including all primary regulations FDA/ISO/PMDA)
•Experience with Advanced Project management (PMP preferred)
•Experience in medical device product development or manufacturing
•Experience in development and integration of complex systems (Hardware, Software, Mechanical)
•Sufficient competency in systems, software/hardware, mechanical, requirements flow down, human factors, reliability, and design controls to ensure best practices are applied, to assess progress and risks, and to make preventive course corrections.
•Experience in creating an effective development plan while aligning relevant Core Team members and stakeholders
•Experience planning and managing the R&D project budget
•Ability to understand, characterize and communicate technical risk
•Excellent verbal / communication skills
•Proven ability of working effectively in a virtual and global team
•Familiar with IEC 60601, IEC 62304, IEC 62366, UL, ANSI and ASTM standards
•Familiar with product cyber security, EU MDR and RoHS
•Experience from multidisciplinary environment & Cross-functional experience in R&D, Operations and Quality.
•Experienced Core Team Member Experience with a track record of successful product launches in the medical device industry
• A background in ablation technologies; an understanding of clinical/technical applications of ablation products and application related physiology
•Experience developing electro-mechanical devices employing real-time embedded systems and graphic user interfaces
•Experienced in working with large, multi-site, matrix organizations.
•Experience with product design related to cardiovascular products.
•PMP certification preferred.
•Experience with Design for Six Sigma, Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Serviceability, Design for Lean Sigma (DFLS) and/or robust design practices
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)
- Bachelors degree required
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
•Bachelor's degree in a relevant technical discipline. Examples: Mechanical, Electrical, Software or Biomedical Engineering
•8 + years of experience managing R&D activities and teams
•6+ years of experience of progressive leadership experience or Advanced Degree
•Experience with engineering of Medical Device Development (including all primary regulations FDA/ISO/PMDA)
•Experience with Advanced Project management (PMP preferred)
•Experience in medical device product development or manufacturing
•Experience in development and integration of complex systems (Hardware, Software, Mechanical)
•Sufficient competency in systems, software/hardware, mechanical, requirements flow down, human factors, reliability, and design controls to ensure best practices are applied, to assess progress and risks, and to make preventive course corrections.
•Experience in creating an effective development plan while aligning relevant Core Team members and stakeholders
•Experience planning and managing the R&D project budget
•Ability to understand, characterize and communicate technical risk
•Excellent verbal / communication skills
•Proven ability of working effectively in a virtual and global team
•Familiar with IEC 60601, IEC 62304, IEC 62366, UL, ANSI and ASTM standards
•Familiar with product cyber security, EU MDR and RoHS
•Experience from multidisciplinary environment & Cross-functional experience in R&D, Operations and Quality.
•Experienced Core Team Member Experience with a track record of successful product launches in the medical device industry
• A background in ablation technologies; an understanding of clinical/technical applications of ablation products and application related physiology
•Experience developing electro-mechanical devices employing real-time embedded systems and graphic user interfaces
•Experienced in working with large, multi-site, matrix organizations.
•Experience with product design related to cardiovascular products.
•PMP certification preferred.
•Experience with Design for Six Sigma, Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Serviceability, Design for Lean Sigma (DFLS) and/or robust design practices
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)
