Device Engineer
GSK
June 30, 2026
Remote friendly (Zebulon, NC)
United States
Operations
Position Summary:
- Join a cross-functional team designing and developing patient-focused delivery devices; lead technical assessments, prototype testing, and risk management with engineering, formulation, quality, and supply.
Responsibilities:
- Lead early device development (concept → feasibility → engineering confidence testing).
- Perform technology scouting/evaluations; design, prototype, and run lab testing and simulations for function, safety, reliability.
- Identify and mitigate technical, manufacturing, and regulatory risks.
- Prepare/maintain device documentation (design history files, risk management files, technical reports).
- Support design for manufacturability and scale-up with internal teams and external partners.
- Act as technical lead for Critical Process Parameters (identify/understand/monitor/control).
- Lead device/equipment investigations: RCA and CAPA.
- Improve process capability, batch yields, and drive Cost of Goods/Cost of Waste improvements.
- Deliver NPI trials and planned change implementation; support equipment installations/validation.
- Maintain validation and life-cycle management expertise (design controls, manufacturing technologies, combination products).
- Coach operators to improve shop-floor issue resolution.
- Lead/support ISO-based life-cycle risk management and periodic risk reviews.
- Create/maintain Device History Files; provide SME input for device complaints.
Required Qualifications:
- 3+ years of device/medical product experience; hands-on CAD for device design and prototype testing.
- Bachelor’s degree in a related scientific/technical discipline (chemical engineering, chemistry, pharmacy, or 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.
- Drug-device systems/combination products experience (e.g., autoinjectors, pre-filled syringes, on-body injectors).
- Regulatory standards familiarity; contract manufacturer/supplier partner experience.
- Rapid prototyping/3D printing/mechanical test method development; multidisciplinary coordination and clear technical communication.
- Proven ability to manage multiple tasks and meet timelines.
Working Model/Travel:
- Hybrid; on-site for lab work/prototype testing/key team activities; occasional travel may be required.
How to Apply:
- Submit your resume with a brief note on what excites you about the opportunity and how you can contribute.
- Join a cross-functional team designing and developing patient-focused delivery devices; lead technical assessments, prototype testing, and risk management with engineering, formulation, quality, and supply.
Responsibilities:
- Lead early device development (concept → feasibility → engineering confidence testing).
- Perform technology scouting/evaluations; design, prototype, and run lab testing and simulations for function, safety, reliability.
- Identify and mitigate technical, manufacturing, and regulatory risks.
- Prepare/maintain device documentation (design history files, risk management files, technical reports).
- Support design for manufacturability and scale-up with internal teams and external partners.
- Act as technical lead for Critical Process Parameters (identify/understand/monitor/control).
- Lead device/equipment investigations: RCA and CAPA.
- Improve process capability, batch yields, and drive Cost of Goods/Cost of Waste improvements.
- Deliver NPI trials and planned change implementation; support equipment installations/validation.
- Maintain validation and life-cycle management expertise (design controls, manufacturing technologies, combination products).
- Coach operators to improve shop-floor issue resolution.
- Lead/support ISO-based life-cycle risk management and periodic risk reviews.
- Create/maintain Device History Files; provide SME input for device complaints.
Required Qualifications:
- 3+ years of device/medical product experience; hands-on CAD for device design and prototype testing.
- Bachelor’s degree in a related scientific/technical discipline (chemical engineering, chemistry, pharmacy, or 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.
- Drug-device systems/combination products experience (e.g., autoinjectors, pre-filled syringes, on-body injectors).
- Regulatory standards familiarity; contract manufacturer/supplier partner experience.
- Rapid prototyping/3D printing/mechanical test method development; multidisciplinary coordination and clear technical communication.
- Proven ability to manage multiple tasks and meet timelines.
Working Model/Travel:
- Hybrid; on-site for lab work/prototype testing/key team activities; occasional travel may be required.
How to Apply:
- Submit your resume with a brief note on what excites you about the opportunity and how you can contribute.