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.
We are seeking a Technical Project Manager who will oversee and manage technical projects within the medical device industry, ensuring compliance with regulatory standards and alignment with ASG’s core values. This role requires strong project management skills, technical expertise, and the ability to lead cross-functional teams to deliver high-quality results in a deadline-driven environment.
Regulatory Compliance and Documentation :
Stay updated on ISO 13485, governmental regulations, and medical device standards.
Create and maintain compliant regulatory documentation.
Ensure documentation meets company and industry requirements.
Project Planning and Execution :
Plan, develop, and execute projects on schedule.
Adjust schedules and targets as project needs or budgets change.
Estimate project timelines and assess technical options' impact.
Maintain technical project documentation.
Conduct project evaluations, After-Action Reviews (AAR), and implement Corrective and Preventive Actions (CAPA).
Project Leadership :
Assign tasks to team members based on their strengths.
Serve as the main contact for multi-unit teams to ensure project alignment.
Resolve technical or project issues with appropriate technical input.
Team Communication :
Align technical, management, quality, and regulatory stakeholders.
Participate in technical meetings, document decisions, track actions, and maintain minutes.
Advise clients on technical challenges and propose solutions.
Risk Management :
Identify project risks (technical, device, design, user-related).
Assess risk impact and likelihood.
Develop risk mitigation strategies.
Maintain detailed risk documentation (descriptions, probabilities, impacts, mitigation, status).
Change Management :
Guide teams in compiling data for change controls.
Ensure data accuracy and compliance in the change control system.
Bachelor’s degree in engineering or a related technical field.
2-5 years of experience in the medical device industry or a similar role.
KSAs
Strong understanding of regulatory principles and practices.
Expertise in Design Controls and product development, including design and validation.
Proficiency in project management and schedule management.
Effective problem-solving and analytical abilities.
Clear verbal and written communication.
Strong teamwork and collaboration.
Excellent time management and organization.
Proficiency in technical decision-making and issue resolution.
Manage multiple projects in a fast-paced environment.
Pay close attention to detail.
Interpret technical procedures and regulations.
Solve complex problems with critical and creative thinking.
Maintain confidentiality of sensitive information.
Prioritize tasks effectively.
Behaviors (Core Values) :
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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