Principal Consultant

This is a fully remote position, open to applicants in Alabama, +4 more states.

📋 Description

• Engage in project management and technical activities related to the development of combination products, assisting clients in delivering life-saving therapies to patients.

• Serve as a technical subject matter expert, leading discussions for both internal and client teams regarding the development of drug delivery systems.

• Ensure program execution aligns with industry standards, external regulatory requirements, and site quality management systems.

• Create design control deliverables to document adherence to medical device development processes.

• Draft comprehensive and clear reports on completed studies, summarizing test results and their alignment with established acceptance criteria.

• Set and uphold project timelines and deliverables, while maintaining accountability for project budgets and overall program execution.

⛳️ Requirements

• Over 10 years of experience as a Principal or Sr. Principal systems engineer, technical lead, or similar role in the development of combination products and/or medical devices.

• Bachelor's degree in Engineering, Biology, Physics, or a related scientific field.

• A Master’s degree in Engineering, Biology, Physics, or a related scientific discipline is preferred.

• Proven technical management of programs in both direct and matrix reporting structures, coordinating and guiding multiple team members in executing program deliverables.

• Familiarity with the complete lifecycle management of medical device programs, with an emphasis on the clinical and commercial development of drug delivery systems (combination products).

• Direct experience in developing design history file documentation within quality management systems, including Design and Development Plans, User Needs, Requirements, Risk Management, Verification, Validation, and Design Transfer.

• Proficient in leading technical discussions for internal and client teams as a technical subject matter expert in drug delivery system development.

• Preferred candidates should have pharmaceutical-related medical device experience with combination products and/or drug delivery systems.

• Knowledge of DHF elements and their integration throughout the medical device development process.

• Solid understanding of medical device processes: Design Controls (21 CFR 820.30), ISO13485, ISO14971.

• Experience with writing and reviewing Standard Operating Procedures (SOPs) is preferred.

• Comfortable working with various quality management systems.

• Experience in supporting regulatory teams with the preparation of regulatory submissions is preferred.

• Highly preferred candidates should have project management experience.

• Familiarity with one or more of the following: Autoinjectors, pre-filled syringes, or on-body delivery systems is a plus.

🏝️ Benefits

• Health insurance

• Professional development

• Flexible work arrangements