Device Engineer
GSK
August 13, 2026
Remote friendly (Zebulon, NC)
United States
Other
Responsibilities:
- Lead early device development 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 device documentation (design history files, risk management files, technical reports).
- Support design for manufacturability and scale-up with internal teams and external partners.
- Serve as technical lead by identifying, monitoring, and controlling Critical Process Parameters.
- Participate in investigations for device/equipment issues; lead quality investigations, RCA, and CAPA.
- Improve unit operation process capability and batch yields; accountable for Cost of Goods and Cost of Waste improvements.
- Deliver key technical activities including NPI trials and planned change implementation.
- Lead/support equipment installation and validation development work.
- Maintain lifecycle validation understanding (design controls, manufacturing technologies, and combination products for commercialization).
- Coach operators to transfer knowledge to the manufacturing shop floor and improve timely issue resolution.
- Lead/support life-cycle risk management and periodic risk reviews per ISO requirements.
- Create/maintain Device History Files; provide SME input for device complaints.
Required Qualifications:
- 3+ years device/medical product experience; hands-on CAD tools for device design and prototype testing.
- Bachelor’s degree in a related scientific/technical discipline (e.g., chemical engineering, chemistry, pharmacy, pharmaceutical engineering).
- Experience with design controls, risk management, and quality processes for medical device development.
Preferred Qualifications:
- Master’s degree and additional device development experience.
- Simulation tools (e.g., finite element analysis) and in-silico modeling.
- Combination products/drug-device systems experience (e.g., autoinjectors, pre-filled syringes, on-body injectors).
- Knowledge of regulatory frameworks/standards for device design, usability, and safety.
- Experience with contract manufacturers/suppliers/external partners on prototyping and scale-up.
- Rapid prototyping (e.g., 3D printing) or mechanical test method development.
- Ability to coordinate multidisciplinary work and communicate technical results.
- Proven ability to manage multiple tasks and meet project timelines.
How to Apply:
- Apply with a resume and a brief note on what excites you and how you can contribute.
- Lead early device development 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 device documentation (design history files, risk management files, technical reports).
- Support design for manufacturability and scale-up with internal teams and external partners.
- Serve as technical lead by identifying, monitoring, and controlling Critical Process Parameters.
- Participate in investigations for device/equipment issues; lead quality investigations, RCA, and CAPA.
- Improve unit operation process capability and batch yields; accountable for Cost of Goods and Cost of Waste improvements.
- Deliver key technical activities including NPI trials and planned change implementation.
- Lead/support equipment installation and validation development work.
- Maintain lifecycle validation understanding (design controls, manufacturing technologies, and combination products for commercialization).
- Coach operators to transfer knowledge to the manufacturing shop floor and improve timely issue resolution.
- Lead/support life-cycle risk management and periodic risk reviews per ISO requirements.
- Create/maintain Device History Files; provide SME input for device complaints.
Required Qualifications:
- 3+ years device/medical product experience; hands-on CAD tools for device design and prototype testing.
- Bachelor’s degree in a related scientific/technical discipline (e.g., chemical engineering, chemistry, pharmacy, pharmaceutical engineering).
- Experience with design controls, risk management, and quality processes for medical device development.
Preferred Qualifications:
- Master’s degree and additional device development experience.
- Simulation tools (e.g., finite element analysis) and in-silico modeling.
- Combination products/drug-device systems experience (e.g., autoinjectors, pre-filled syringes, on-body injectors).
- Knowledge of regulatory frameworks/standards for device design, usability, and safety.
- Experience with contract manufacturers/suppliers/external partners on prototyping and scale-up.
- Rapid prototyping (e.g., 3D printing) or mechanical test method development.
- Ability to coordinate multidisciplinary work and communicate technical results.
- Proven ability to manage multiple tasks and meet project timelines.
How to Apply:
- Apply with a resume and a brief note on what excites you and how you can contribute.