Engineering Manager

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all You ll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the Life Responsibilities may include the following and other duties may be assigned Lead and mentor cross-functional teams to develop comprehensive signal evaluation reports product risk management files including risk management plans Hazard Analysis DFMEA and risk management reports adhering to ISO 14971 standards Oversee the preparation and compilation of product post-market data and findings into comprehensive Periodic Safety Update Reports PSURs in compliance with regulatory requirements ensure accurate and timely submission of clinical evaluation plans reports Conduct thorough reviews of new and modified product design documentation assessing quality characteristics such as manufacturability serviceability testability reliability and compliance with product requirements Ensure compliance with FDA Quality System Regulations EU MDR ISO 13485 ISO 14971 IEC 60601 and other relevant industry standards during product development and changes Review Design History Files and Technical Files to ensure alignment with applicable requirements Deliver presentations on project status and issues to the QA organization and provide training to other departments on relevant procedures and policies Participate in audits and demonstrate the ability to effectively contribute as a team player in various roles including contributor subject matter expert leader and facilitator Provide quality support to facilitate the resolution of product complaints and or safety issues Develop templates and training based on quality system regulations applicable standards and guidance Independently review all deliverables to ensure compliance with development processes and standards Stay updated with evolving safety regulations and guidelines to ensure compliance Required knowledge and Experience B E or B Tech in Mechanical Biomedical Engineering Minimum 16 years of engineering experience with at least 5 years in a people leading role in medical device domain Capability to conduct thorough reviews of product design documentation and assess quality characteristics Hands-on experience with leading diverse teams resolving complex techno-managerial challenges with proven track record Strong verbal and written communication skills Key Technical Competencies Familiarity with ISO 9001 ISO 13485 ISO 14971 IEC 60601 21 CFR part 820 21 CFR part 11 EU MDR and product-specific industry standards Working knowledge of and auditing experience with FDA Quality System Regulations ISO 13485 and the Medical Device Regulation People Management Soft Skills Requirements Leadership Proven ability to lead mentor and develop high-performing teams fostering a collaborative and inclusive work environment Communication Excellent verbal and written communication skills with the ability to convey complex information clearly and effectively to diverse audiences Problem-Solving Strong analytical and problem-solving skills with a proactive approach to identifying and addressing issues Interpersonal Skills Ability to build and maintain strong relationships with cross-functional teams stakeholders and regulatory authorities Adaptability Demonstrated ability to adapt to changing priorities and manage multiple projects simultaneously in a fast-paced environment Conflict Resolution Skilled in conflict resolution and negotiation with the ability to handle challenging situations with professionalism and tact Decision-Making Strong decision-making skills with the ability to make informed and timely decisions that align with organizational goals Medical Device domain Ability to understand the functionality intended use of complex medical devices Nice to Haves ASQ CQE CQA CSQE and or CRE certification ISO 9001 Internal Auditor Lead Auditor Certification ISO 13485 Internal Auditor Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Understanding of post-market surveillance processes and adverse event reporting Knowledge of risk management principles and hazard analysis in the context of medical devices Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position Benefits Compensation Medtronic offers a competitive Salary and flexible Benefits Package 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 About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions Our Mission to alleviate pain restore health and extend life unites a global team of 95 000 passionate people We are engineers at heart putting ambitious ideas to work to generate real solutions for real people From the R D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves We have the talent diverse perspectives and guts to engineer the extraordinary Learn more about our business mission and our commitment to diversity