Device Engineer

GSK•Zebulon, NC

1d•Hybrid

About The Position

You will join a cross-functional team designing and developing patient-focused delivery devices. You will lead technical assessments, prototype testing, and risk management while working closely with experts across engineering, formulation, quality, and supply. We value practical problem-solvers who are curious, collaborative, and focused on building safe, reliable, and manufacturable solutions. This role offers clear growth, the chance to shape next-generation device technologies, and meaningful impact aligned with our mission of uniting science, technology and talent to get ahead of disease together.

Requirements

3 + years of device or medical product experience with hands-on experience using CAD tools for device design and running prototype testing.
Bachelor's degree in a related scientific or technical discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering.
Experience with design controls, risk management and quality processes used in medical device development.

Nice To Haves

Master’s degree in engineering or related field and additional device development experience.
Experience with simulation tools (for example finite element analysis) and in-silico modelling.
Experience in combination products or drug-device systems, including autoinjectors, pre-filled syringes, or on-body injectors.
Familiarity with regulatory frameworks and standards relevant to device design, usability, and safety.
Experience working with contract manufacturers, suppliers, or external partners on prototyping and scale-up.
Hands-on skills in rapid prototyping, 3D printing, or mechanical test method development.
Ability to coordinate multidisciplinary work and communicate technical results clearly.
Proven record of managing multiple tasks and delivering to project timelines.

Responsibilities

Lead early device development activities from concept through feasibility and engineering confidence testing.
Perform technology scouting and technical evaluations to identify suitable device solutions.
Design, prototype, and run lab-based testing and simulations to verify device function, safety, and reliability.
Identify and drive mitigation for technical, manufacturing and regulatory risks.
Prepare and maintain core device documentation such as design history files, risk management files, and technical reports.
Work with internal teams and external partners to support design for manufacturability and scale-up.
Act as technical lead for the device ensuring Critical Process Parameters are identified, understood, monitored and controlled.
Actively participate in the investigation team for device and equipment related issues.
Lead quality investigations, RCA and CAPA associated with the device.
Drive the improvement of unit operation process capability and batch yields.
Be accountable for Cost of Goods and Cost of Waste improvements.
Responsible for delivering key technical activities including NPI trials and planned change implementation.
Lead/support development work in support of equipment installations and validation.
Maintain a strong level of validation understanding and proficiencies within life cycle management, including expertise in design controls, manufacturing technologies and upcoming combination products for commercialization.
Able to perform technical coaching of operators to ensure knowledge transfer to the manufacturing shop floor allowing operators to improve their accountability and timeliness of issue resolution.
Lead/support risk management activities through the life cycle for devices and conduct periodic risk reviews based on ISO requirements.
Create/Maintain Device History Files.
Provide technical SME input for complaints related to the device.