Principal Consultant

We offer integrated, comprehensive solutions that address complex technical, clinical development, and safety and regulatory challenges, leveraging our deep scientific, medical, and regulatory expertise and real-world experience. Our goal is to help you complete projects efficiently and with less risk, leading to solutions for a healthier and safer world.

With a broad range of renowned scientific, medical, regulatory, and engineering specialists under one roof, we streamline your project and reduce your workload, so you can make sound, science-based decisions about human and environmental health issues.

BlueRidge Life Sciences is a growing family of companies providing a comprehensive suite of life sciences services, spanning toxicology, regulatory science, risk assessment, epidemiology, biostatistics, engineering, clinical research, health economics, pharmaceutical commercialization, and environmental consulting. Across these specialized areas, we collaborate to deliver science-driven solutions that support industries including pharmaceuticals, biotechnology, medical devices, chemicals, foods and consumer products. Our collective expertise helps clients navigate regulatory requirements, assess safety and efficacy, manage risks, and optimize pharmaceutical commercialization strategies.

If you’re ready to achieve your life science goals, there’s no better partner than BlueRidge Life Sciences.  

Job Description:

We are Suttons Creek, LLC We are a fully remote consultancy that supports the medical device, pharmaceutical, and biotechnology industries in bringing life-saving therapies to patients faster. We work with companies all over the world and are looking for highly motivated people that want to contribute to making an impact in peoples’ lives.

ABOUT YOU:

You're ambitious, detail-oriented, and quite frankly, you get stuff done. You don’t need to be told what to do because you can look around, see what needs to be done, and do it. You want to be exposed to all facets of a company, and you have what it takes to drive everything from small, administrative tasks, to large, business critical projects. You love to learn, you have a strong work ethic, and you've never said the words, "that's not my job." You're relentlessly optimistic, and you bring "good energy" everywhere you go. You thrive in fast paced, highly entrepreneurial environments.

SOME OF THE THINGS YOU'LL DO:

We are actively seeking team members who can serve as critical members of our Technical Services Team in delivering solutions for our client base. In this role you will participate in the project management and technical work of combination product development and the nuances of this complex regulatory environment as you support out client’s in bringing live-saving therapies to patients. You will report directly to the Director, Technical Service and take direction from him/her on client-related projects. Desired candidates will have a breadth of exposure defined by the following experience:

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

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

• 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.
• 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.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• 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
• 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

Physical Demands and Work Environment

Office Environment: This role is fully remote and you will work from your home office. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions