Technical Project Manager

Adjutant Solutions Group•Indianapolis, IN

10d

About The Position

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.

Requirements

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 of Regulatory and governing agency principles and practices
Knowledge of Design controls and execution of design control activities within product development
Knowledge of Drug–device combination product development and regulatory considerations
Knowledge of Project management methodologies, tools, and best practices
Knowledge of Project scheduling development, maintenance, and deliverables tracking
Knowledge of 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
Ability to manage multiple projects in a fast-paced, deadline-driven environment
Ability to maintain attention to detail and data accuracy
Ability to interpret technical documents and regulatory requirements
Ability to apply critical thinking to develop creative solutions
Ability to prioritize competing demands effectively
Ability to maintain confidentiality and handle sensitive information

Responsibilities

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