Engineering Program/Project Management

Indotronix International Corporation • San Diego, CA

2d • Onsite

About The Position

Join a collaborative, high-impact team as an Engineering Program/Project Manager, leading critical cross-functional projects focused on technical dossier audits and regulatory readiness for in-market clinical diagnostic products. This is a unique opportunity to drive regulatory compliance efforts, partner with diverse business units, and play a pivotal role in ensuring continued global market access for innovative healthcare solutions.

Requirements

• Bachelor’s degree in engineering, scientific, regulatory, or related discipline
• 3-5 years’ project management experience in a regulated industry such as medical devices, IVD, biotechnology, or life sciences
• Working knowledge of product development documentation, design controls, and regulatory submissions
• Proven ability to lead cross-functional teams and manage multiple priorities
• Strong planning, organization, and risk management capabilities
• Excellent written and verbal communication, meeting facilitation, and presentation skills
• Detail-oriented, with a strong commitment to quality and compliance
• Proficient in Microsoft Office Suite and project management tools

Nice To Haves

• Experience with documentation remediation, compliance assessments, or global regulatory frameworks
• Familiarity with project management, document management, or product lifecycle management systems
• Knowledge of global medical device and IVD regulatory requirements
• Experience supporting regulatory submissions or product registrations
• Project Management Professional (PMP) certification

Responsibilities

• Lead technical dossier audit and documentation projects supporting regulatory re-registration and product sustainment activities
• Develop and manage integrated project plans, milestones, and progress-tracking tools to meet regulatory objectives
• Coordinate systematic reviews of design history files, risk management files, and other key regulatory deliverables
• Facilitate gap assessments, identify compliance issues, and drive remediation plans with subject matter experts
• Manage project risks and dependencies, escalating issues as needed to keep initiatives on track
• Organize and facilitate team meetings, reviews, and working sessions; record and communicate action items and decisions
• Maintain accurate project documentation, dashboards, and status updates for leadership and stakeholders
• Ensure all activities meet applicable quality system and regulatory requirements
• Support continuous improvement of technical documentation and project execution processes
• Apply project management best practices to foster team alignment and accountability

Benefits

• Competitive bill rate: $55-$70/hour
• Opportunity to impact regulatory compliance and product success on a global scale
• Collaborative, cross-functional work environment with exposure to Regulatory Affairs, R&D, Quality, and more
• Career growth potential within the rapidly evolving medical device and diagnostics sector

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level