Senior Risk Management Engineer

GSK • Upper Providence, PA

1d • Hybrid

About The Position

The Device Risk Management Lead is accountable for establishing, executing, and continuously improving risk management for medical devices and drug–device combination products across PDDS, in accordance with ISO 14971 and applicable global regulations, including EU MDR 2017/745 and FDA 21 CFR 820. The role provides subject-matter expertise in device risk management, owns key risk files and processes, and ensures risk controls are identified, implemented, and verified to support safe and effective products throughout their lifecycle.

The role serves as risk owner for designated device and combination-product programmes, leads risk assessments, develops risk frameworks and documentation, and facilitates cross-functional work to identify hazards and associated harms. It also supports regulatory and audit readiness and builds risk-management capability among site and project teams. The position is hybrid, with regular on-site presence required at either the Ware RD site in the United Kingdom or the Upper Providence site in the United States.

Requirements

• Degree in Engineering, Science, Risk Management, or a related discipline, or equivalent experience.
• Strong experience in risk management or reliability roles within regulated manufacturing or life sciences.
• Practical experience with ISO 14971 risk methodologies such as Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), or similar.
• Strong collaboration skills and experience working with engineering, quality, operations, and procurement teams.
• Clear written and verbal communication skills, including the ability to present complex issues simply to different audiences.

Nice To Haves

• Experience in pharmaceutical or medical device environments and a good understanding of GMP expectations.
• Formal risk or quality qualifications, such as IRCA, CQE, or equivalent training.
• Familiarity with regulatory risk expectations and inspection interactions.
• Comfort using digital tools for data analysis, risk tracking, and reporting.
• Experience coaching teams and embedding risk-led cultures across sites.
• Strong analytical and structured problem-solving skills, including the ability to synthesise technical and clinical information into clear risk assessments.

Responsibilities

• Serve as PDDS risk owner for designated device and combination-product programmes, own the Risk Management File (RMF), and lead design, use, process, and manufacturing risk assessments.
• Design and maintain risk frameworks, tools, and documentation to support consistent decision-making.
• Run failure mode analysis, hazard assessments, and root cause investigations with cross-functional teams.
• Lead cross-functional risk assessment workshops with Human Factors, Device Engineering, Formulation, Primary Packaging, Clinical, Safety, Regulatory, Quality, and Manufacturing stakeholders to identify hazards, hazardous situations, foreseeable misuse, and associated harms.
• Support regulatory and audit readiness by preparing risk rationales and evidence for inspections.
• Coach and develop site and project teams in risk thinking, tools, and best practices.

Benefits

• Access to learning, mentorship, and stretch opportunities.
• Meaningful work connecting science and technology to improve health.
• Agile working culture; applicants are encouraged to discuss flexibility with the hiring team.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed