6307 - Systems Engineer / Senior Project Engineer

Responsibilities

• Solicit, manage, and document stakeholder needs and requirements across constituent systems
• Perform requirements analysis, development, allocation, and management
• Create and maintain traceability from requirements (including system risk) to system verification and validation
• Manage requirements flow-down and interface requirements between constituent systems
• Develop and document system test strategies
• Lead system integration, verification, and validation activities across constituent systems
• Participate in design reviews and contribute SE deliverables aligned with regulations and standards
• Develop and document system architecture including concept trade-offs, functional analysis, and interface definitions
• Apply systems thinking to understand how constituent systems interact within the broader product ecosystem
• Define and manage system boundaries and interfaces between constituent systems
• Support system-level hazard identification
• Collaborate on risk documentation and maintaining risk management files
• Apply hazard analysis techniques (FTA, FMEA) to support product safety throughout the development lifecycle
• Participate in the systems engineering community of practice to stay current with tools, techniques, and regulatory expectations
• Drive continuous process improvement focused on SE-related processes and tools
• Proactively identify and communicate quality issues

Requirements

• Bachelor’s degree in an engineering field with 5+ years of relevant experience
• Demonstrated experience creating systems engineering work products (e.g. stakeholder requirements document, system requirements document, V&V matrices, etc)
• Proficiency with requirements management
• Strong technical writing skills for protocols, reports, and regulatory submissions
• Experience with drug delivery devices (autoinjectors, pen injectors, wearables, inhalers) or combination products
• Knowledge of ISO 14971 (risk management), ISO 13485 (quality management), and FDA 21 CFR Part 820 (design controls)
• Experience with hazard analysis techniques (FTA, FMEA) and risk management activities

Qualifications

Qualified candidates must be legally authorized to be employed in the United States

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement