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Adjutant Solutions Group

Technical Project Manager

Project ManagementPosted on Nov 11
Full-timeIndianapolis, IN, USANo salary listedIn-person

About the Job

Requirements

  • Bachelor’s degree in Biomedical Engineering or a related field.
  • Two to five 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 skills.
  • Effective verbal and written communication skills.
  • Team collaboration and interpersonal effectiveness.
  • Time management and organizational skills.
  • Technical decision-making and issue resolution skills.
  • 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 Corrective and Preventive Action (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, including design, device, user-related, and combination product risks.
  • Evaluate risk probability and impact.
  • Develop and implement risk 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.

About the Company

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