We are seeking an experienced Technical Product Owner to lead the development of innovative Electronic Device History Records (EDHR) solutions for medical device manufacturers. The ideal candidate will combine deep regulatory knowledge with technical expertise to create digital solutions that streamline compliance while enhancing manufacturing efficiency. **Key Responsibilities-** Lead the vision, strategy, and roadmap for our Electronic Device History Records platform Translate complex regulatory requirements into comprehensive product features and specifications Collaborate with medical device manufacturers to understand their compliance challenges and operational needs Develop solutions that integrate with existing manufacturing systems and quality management processes Prioritize development activities based on regulatory requirements, customer value, and business objectives Manage the product backlog and guide development teams through effective sprint planning Serve as the subject matter expert on medical device regulations related to manufacturing documentation Drive the digitalization of medical device manufacturing processes with focus on DHR compliance Support pre-sales activities with technical presentations and regulatory compliance demonstrations Stay current with evolving regulations and industry standards for medical device manufacturing Ensure solutions meet FDA, EU MDR, and other global regulatory requirements HTSIND2025 **Qualifications-** 7 to 10 years of experience in the life sciences industry with specific focus on medical device manufacturing Comprehensive understanding of medical device regulations including DHF, DHR, MDR, and technical documentation requirements Experience in digitalizing medical device manufacturing processes Strong knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and other applicable regulations Demonstrated expertise in electronic records compliance (21 CFR Part 11) Experience with product lifecycle management (PLM) systems, MES, or quality management systems Proven track record of successfully implementing electronic documentation solutions in regulated environments Experience with Agile development methodologies Strong analytical and problem-solving skills Excellent communication abilities and stakeholder management experience Bachelor's degree in Engineering, Computer Science, or related technical field; Advanced degree preferred **PreferredExperience-** Direct experience implementing EDHR solutions for Class II or Class III medical devices Background in medical device manufacturing operations or quality assurance Experience with UDI implementation and product traceability systems Knowledge of risk management processes according to ISO 14971 Familiarity with software validation processes for medical device manufacturing systems Understanding of audit processes and regulatory inspections Experience with change control and configuration management in regulated environments If you have a passion for improving medical device manufacturing through digital transformation and possess the expertise described above, we welcome your application. Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.