Key skills
RStatistical AnalysisRisk ManagementCommunication
About this role
Role Overview
- Serve as the risk management subject matter contributor on assigned New Product Development programs
- Assess potential patient and user risks associated with products under development
- Develop, update, and maintain risk management documentation, including: Hazard analyses, Risk assessments (e.g., URRA / user risk reliability assessments), Risk controls and verification activities
- Incorporate FDA feedback and evolving regulatory expectations into risk documentation across programs
- Collaborate with the program’s Quality Core Team Member (QCTM) and broader cross‑functional core teams
- Support ongoing updates to quality system documents and procedures related to risk management
- Contribute to process improvements and special quality projects as needed
- Communicate risk‑related impacts clearly across multidisciplinary stakeholders
Requirements
- Bachelor’s degree in Engineering or a related technical field plus 2 years of applicable experience, OR Master’s degree in Engineering or a related field with 1+ year of applicable experience
- Hands-on experience with risk analysis and risk management within a regulated industry
- Technical background in both mechanical and electromechanical systems
- Experience in medical devices, pharmaceuticals, or combination products
- Familiarity with medical device risk management standards (e.g., ISO 14971 concepts)
- Prior involvement in New Product Development (NPD) environments
- Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles
- Clinical knowledge or experience supporting clinical risk assessment
- Experience using Minitab or other statistical analysis software
- Certification or experience with Design for Six Sigma / Design for Reliability methodologies
- Strong written, verbal, and digital communication skills
- Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)
- Authorization to work in the United States without the need for future visa sponsorship.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- 401(k) plan plus employer contribution and match
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)