6307 - Systems Engineer / Senior Project Engineer

Veristainc; Indianapolis (IN); On-site; USD 85,000 - 127,144; Full time

Benefits offered by this job

High growth potential

401(k) Retirement Plan

Paid Time Off

Job summary

Verista is looking for a Systems Engineer in Indianapolis, IN, to manage stakeholder requirements, system design, and risk management. The ideal candidate should have a Bachelor's degree in engineering and over 5 years of relevant experience.

Responsibilities include ensuring compliance with FDA regulations and contributing to continuous improvement efforts. The salary range is competitive at $85,000 to $127,144 per year, with various benefits and a focus on employee well-being.

Qualifications

• 5+ years of relevant experience in systems engineering.
• Experience with drug delivery devices or combination products.
• Knowledge of FDA regulations and industry standards.

Responsibilities

• Document stakeholder needs and requirements across systems.
• Develop system test strategies and lead verification activities.
• Define system architecture and manage design interfaces.
• Support risk identification and management activities.
• Drive continuous process improvement in systems engineering.

Skills

Requirements management

Technical writing

ISO 14971 knowledge

Hazard analysis techniques

Education

Bachelor’s degree in engineering

Job description

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world–class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Systems Engineer Responsibilities

• Requirements & Traceability: 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.
• Integration & Verification: 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.
• System Design & Architecture: 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.
• Risk Management: Support system‒level hazard identification and participate in risk identification, assessment, and management activities; collaborate on risk documentation and maintaining risk management files; apply hazard analysis techniques (FTA, FMEA) to support product safety throughout the development lifecycle.
• Continuous Improvement & Quality: 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
• Qualified candidates must be legally authorized to be employed in the United States
• Onsite job requirement in Indianapolis, IN

Salary

National (US) Range: $85,000 — $127,144 USD

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
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Verista is an equal opportunity employer.