BS in Engineering, Science, or related field; MS preferred
5+ years of experience in regulated industries, specifically in pharmaceutical or medical device development
Expertise in Systems Engineering principles and risk management methodologies
Familiarity with FDA regulations and ISO standards
Strong organizational and communication skills, capable of influencing across teams
Proficient in project tracking and document management tools
Experience with third-party vendor management and multicultural awareness
Responsibilities
Lead planning and coordination of use-related risk analysis activities
Facilitate cross-functional meetings to gather timely inputs
Partner with experts to document hazards and risks accurately
Monitor project milestones and escalate issues proactively
Support development of URRA documentation for inspections
Drive consistency in URRA processes and identify improvement opportunities
Support broader systems engineering activities including risk assessments and change management
Benefits
Collaborative work environment with a global team
Opportunities for professional development and growth
Engagement in innovative product development
Exposure to cross-functional teams and diverse expertise
Contribution to patient-centric product design and safety standards
Full Job Description
Position Summary:
As a Systems Engineer with a primary focus on Use-Related Risk Analysis (URRA), you will be responsible for coordinating and driving the successful completion of use-related risk analyses for drug products and associated delivery systems - including on-body devices, pre-filled syringes, autoinjectors, mixing devices, and complex electromechanical pumps.
You will integrate inputs and risks from multiple disciplines to ensure robust, patient-centric product design and performance, while partnering closely with cross-functional stakeholders across human factors, quality, clinical, medical safety, development, and manufacturing teams.
Working alongside a global team of scientists, engineers, and leaders, your expertise and leadership will ensure that all systems are safe, effective, and aligned with applicable internal procedures, regulatory expectations, and quality standards - for both clinical and commercial development programs.
Roles and Responsibilities:
Lead planning and coordination of creating use-related risk analysis activities across all assigned programs.
Facilitate cross-functional meetings to drive development of use-related risk analyses, ensuring team members provide timely inputs for which they are responsible.
Partner with functional experts - including human factors, quality, clinical, medical safety, development, and manufacturing - to support accurate documentation of hazards, use scenarios, failure modes (i.e., use errors), risks, and mitigations.
Monitor progress against milestones and proactively escalate risks, delays, and unresolved issues to appropriate stakeholders.
Support team development and review of URRA documentation to ensure delivery of inspection-ready records to the URRA owner.
Drive consistency in URRA process execution and continuously identify opportunities for process improvement.
In support of the broader systems engineering framework, you will support the following activities and deliverables:
System Architecture & Integration
User and Stakeholder Needs Definition
Use Case Analysis
Standards Coverage Analysis
Product Requirements Definition
Traceability
Risk Management planning and reporting
System Risk Assessment
Use-Related Risk Assessments, Design FMEAs, and Process FMEAs
Change Management
Oversight and integration of Third-Party Development activities
Integration of Design Control and Quality by Design (QbD) activities
Experience:
Demonstrated ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
Expertise in end-to-end product development from initial concept through market release, with direct experience in combination product or medical device development; familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred.
Expertise in Systems Engineering principles including user and stakeholder need definition, requirements definition, risk management, product architecture, configuration management, traceability, and change management.
Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
Working knowledge of use-related risk analysis, human factors, and risk management methodologies.
Strong organizational, facilitation, and communication skills with the ability to influence across a matrixed organization and manage competing priorities.
Strong analytical and decision-making skills; self-driven and proactive in approach.
Experience creating and managing project schedules and identifying project risks and mitigation plans.
Proficiency with project tracking and document management tools.
Experience interfacing with third-party vendors, including communication management, deliverable acceptance testing, and multi-cultural awareness.
Education & Experience:
BS in Engineering, Science, or a closely related discipline with 5+ years of relevant experience; or MS with 3+ years of experience.
3-5 years of experience specifically in pharmaceutical, medical device, combination product, or other regulated industry environments preferred.
Demonstrated scientific writing skills and strong verbal communication skills.
Ability to multitask effectively and deliver results within established timelines.
Experience supporting drug product and delivery system development.
Familiarity with relevant human factors and risk management regulatory expectations.
Ability to synthesize complex technical input into clear, actionable plans and documentation.
Demonstrated proactive, collaborative approach in a fast-paced, highly matrixed environment.
Experience in vendor communication, management, and deliverable acceptance testing.
