Principal Consultant

BlueRidge Life Sciences • Remote - Arizona, CT

1d • Remote

About The Position

We are Suttons Creek, LLC, a fully remote consultancy dedicated to supporting the medical device, pharmaceutical, and biotechnology industries in accelerating the delivery of life-saving therapies to patients. We collaborate with companies globally and are seeking highly motivated individuals eager to make a significant impact on people's lives.

We are actively seeking team members to serve as critical components of our Technical Services Team, delivering innovative solutions to our client base. In this role, you will engage in project management and technical work related to combination product development, navigating the complexities of this intricate regulatory environment to support our clients in bringing life-saving therapies to patients. You will report directly to the Director, Technical Service and receive direction from them on client-related projects. Desired candidates will possess a broad range of experience defined by the following:

The Principal Systems Engineer will report directly to our Director of Technical Services and take direction from him/her on client-related projects.

Requirements

• 10+ years as Principal or Sr. Principal system 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
• 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
• 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

Nice To Haves

• Master’s degree in Engineering, Biology, Physics or related Scientific discipline is desired.
• Preferred that candidate has pharmaceutical-related medical device experience on combination products and/or drug delivery systems
• 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

Responsibilities

• Leading 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
• Development of design control deliverables to document compliance to medical device development processes
• May help as Subject Matter Expert (SME), reviewer, or approver of controlled documents within area(s) in of competency
• 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.
• Apply the application of standards and regulatory requirements to the development of medical devices.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal