Advanced Software Engr

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

HTSIND2025Qualifications-

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


Preferred Experience-

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.

Additional Information

• JOB ID: HRD262716
• Category: Engineering
• Relocation Tier: Not Applicable
• Security Clearance:
• Aviation Authority (FAA for US):
• Band: 03
• Referral Bonus: 50000
• Requisition Type: Standard Requisition
• US Citizenship:
• FLSA Statement:
• FLSA CODE: Exempt