Honeywell Advanced Software Engr 

Philippines, Pampanga 

54414046

Lead the vision, strategy, and roadmap for our Electronic Device History Records platform
Translate complex regulatory requirements into comprehensive product features and specificationsDevelop solutions that integrate with existing manufacturing systems and quality management processes
Prioritize development activities based on regulatory requirements, customer value, and business objectivesServe 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
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 preferredDirect experience implementing EDHR solutions for Class II or Class III medical devices
Background in medical device manufacturing operations or quality assuranceKnowledge 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 environmentsAdditional Information

• JOB ID: HRD262716
• Category: Engineering
• Location: HW Camp II,Bldgs 9A&9B,Plot C2,RMZ Ecoworld,Varturhobli,Sarjapur Marathahalli Outer Ring Road,Bangalore,KARNATAKA,560103,India
• Exempt