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ASG specializes in the development, qualification, and commercialization of drug delivery systems for biomedical products. We deliver integrated business and science solutions to foster healthier, safer, and more prosperous communities. Guided by our core values—service, client success, curiosity, respect, integrity, and accountability—we value diversity and prioritize collaboration and growth within our inclusive, team-oriented culture.  Check out our GOASG website. 

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.

• 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

• 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

• 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

• 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

• 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

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

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

• 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

• 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

• 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

• 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

• Accountability: Owning the consequences of your decisions and actions.
• Integrity: Complete harmony in what you think, say, and do concerning the ASG Way and our Code of Conduct.
• Respect: Treating people the way you want to be treated, whether or not you agree with them.
• Curiosity: An enduring desire to learn and grow.
• Client Service: Results that address client needs based on client decisions.
• Service: Giving priority to enriching the lives of others.

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