Senior Risk Management Engineer
GSK•Upper Providence, PA
•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 (e.g. EU MDR 2017/745, FDA 21 CFR 820). The role provides subject-matter expertise in device risk management, owns key risk files and processes, and ensures that risk controls are appropriately identified, implemented, and verified to support safe and effective products throughout the lifecycle.
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 ISO14971 risk methodologies such as Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA) or similar.
- Strong collaborator with experience working alongside engineering, quality, operations and procurement teams.
- Clear written and verbal communication skills, able to present complex issues simply to different audiences.
Nice To Haves
- Experience in pharmaceutical or medical device environments with good understanding of GMP expectations.
- Formal risk or quality qualifications (for example IRCA, CQE, or equivalent training).
- Familiarity with regulatory risk expectations and inspection interactions.
- Comfortable 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 with 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, owning the Risk Management File (RMF) and leading risk assessments (e.g. Design Risk Assessment, Use Risk Assessment, Process/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 uplift site and project teams in risk thinking, tools and best practice.
Benefits
- Access to learning, mentorship and stretch opportunities.
- Part of meaningful work that connects science and technology to improve health.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
