Principal Consultant

ToxStrategies, a BlueRidge Life Sciences Company

Principal Consultant at BlueRidge Life Sciences managing technical work in medical devices and biotechnology. Supporting clients in delivering life-saving therapies through effective project management.

Posted 7/21/2026full-timeRemote • Alabama, California, Colorado, Connecticut, Illinois • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in the development and lifecycle management of combination products and medical devices, with a strong focus on design control, regulatory compliance, and project management. Proven ability to lead technical discussions and manage cross-functional teams to deliver high-quality drug delivery systems.

Highest-signal resume keywords

10+ Years Experience In Medical Device DevelopmentDesign Control DocumentationProject Management ExpertiseTechnical Subject Matter ExpertRegulatory Compliance Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Design History File DocumentationRisk ManagementVerification And ValidationDesign TransferClinical DevelopmentCommercial DevelopmentDrug Delivery SystemsCombination ProductsQuality Management SystemsSOP Writing

Soft Skills

LeadershipCommunicationCollaborationAccountabilityTechnical Discussion Facilitation

Industry Keywords

21 CFR 820.30ISO13485ISO14971Medical Device ProcessesPharmaceutical-Related ExperienceAutoinjectorsPre-Filled SyringeOn-Body Delivery Systems

About the role

Key responsibilities & impact

Participate in the project management and technical work of combination product development and support clients in bringing life-saving therapies to patients.
Lead technical discussion for internal and client teams as a technical subject matter expert on the development of drug delivery systems
Align program execution with industry standards, external regulatory requirements and site quality management systems
Develop design control deliverables to document compliance to medical device development processes
Prepare detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria
Establish and maintain project timelines and deliverables and maintain accountability for project budgets and program execution.

Requirements

What you’ll need

10+ years as Principal or Sr. Principal systems engineer, technical lead, or equivalent experience in the development of combination products and/or medical devices.
BS in Engineering, Biology, Physics or related Scientific discipline
Master’s degree in Engineering, Biology, Physics or related Scientific discipline is desired.
Technical management of programs in both direct or matrix reporting organizations, coordinating and leading multiple team members through the execution of program deliverables.
Experience with the total lifecycle management of medical device programs, with preferred experience in the clinical and commercial development of drug delivery systems (combination products)
Direct experience developing design history file documentation in quality management systems, including Design and Development Plans User needs Requirements Risk management Verification Validation Design Transfer
Experienced in leading technical discussion for internal and client teams as a technical subject matter expert on the development of drug delivery systems
Preferred that candidate has pharmaceutical-related medical device experience on combination products and/or drug delivery systems
Understanding of DHF elements, and their integration through the medical device development process.
Thorough understanding of medical device processes: Design Controls (21 CFR 820.30) ISO13485 ISO14971
Preferred SOP Writing and Review
Experience with, as well as experience and flexibility to work under a number of different quality management systems
Preferred, experience supporting regulatory teams in the authoring of regulatory submissions
Highly preferred, Experience with project management
Experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems is a plus

Benefits

Comp & perks

Health insurance
Professional development
Flexible work arrangements