Technical Project Manager

Position Summary

ASG is seeking a highly capable Technical Project Manager to lead and execute complex technical projects within the medical device space. This role requires strong ownership, autonomy, and the ability to manage multiple priorities with minimal supervision.

The ideal candidate brings a strong understanding of technical project management principles, including design controls, change control, deliverable tracking, scheduling, and drug–device combination products, along with regulatory requirements and cross-functional collaboration.

Key Responsibilities

Documentation & Regulatory Knowledge

• Stay current with ISO 13485, governmental regulations, medical device standards, and drug–device combination product requirements
• Support and prepare regulatory documentation to meet industry and compliance requirements
• Create and maintain documentation aligned with company policies and applicable regulations

Project Planning & Execution

• Analyze, plan, and execute project timelines and deliverables
• Develop and maintain detailed project schedules, ensuring accuracy and alignment with technical and business needs
• Track and manage project deliverables to ensure timely and quality completion
• Adjust schedules and targets based on scope changes, risks, or funding considerations
• Assess schedule impacts of technical decisions and options
• Create, update, and maintain project documentation
• Lead project evaluations, After-Action Reviews (AAR), and CAPA implementation

Project Leadership & Management

• Delegate tasks effectively to optimize team performance
• Serve as a central point of contact across cross-functional teams
• Manage technical and project issues through resolution, providing technical input when needed

Communication & Stakeholder Engagement

• Drive alignment across technical, quality, regulatory, and management stakeholders
• Participate in and facilitate technical meetings, documenting actions and outcomes
• Provide consultative guidance on technical challenges and present solution options to clients

Risk Management

• Identify, assess, and document project risks (design, device, user-related, and combination product risks)
• Evaluate risk probability and impact
• Develop and implement mitigation strategies
• Maintain comprehensive risk registers with status tracking

Change Management

• Guide teams through change control processes and data compilation
• Manage and maintain data within a change control system to ensure accuracy, consistency, and compliance

Leadership & Team Development

• Mentor junior team members and interns in alignment with ASG growth initiatives

Qualifications

• Bachelor's degree in Biomedical Engineering or a related field
• 2–5 years of experience in the medical device, drug–device combination product, or a similarly regulated industry

Knowledge, Skills, Abilities & Behaviors

Knowledge

• Regulatory and governing agency principles and practices
• Design controls and execution of design control activities within product development
• Drug–device combination product development and regulatory considerations
• Project management methodologies, tools, and best practices
• Project scheduling development, maintenance, and deliverables tracking
• Change control processes and systems

Skills

• Strong analytical thinking, problem-solving, and troubleshooting
• Effective verbal and written communication
• Team collaboration and interpersonal effectiveness
• Time management and organizational skills
• Technical decision-making and issue resolution

Abilities

• Manage multiple projects in a fast-paced, deadline-driven environment
• Maintain attention to detail and data accuracy
• Interpret technical documents and regulatory requirements
• Apply critical thinking to develop creative solutions
• Prioritize competing demands effectively
• Maintain confidentiality and handle sensitive information