Position Overview
The Systems Engineer – Assay Development will be a key contributor within the R&D organization, responsible for driving systems engineering activities across assay development projects. This role focuses on requirements definition, risk management, and verification and validation (V&V) in a regulated IVD/medical device environment.
The successful candidate will take ownership of system-level deliverables, support system architecture development, and enable informed decision-making by evaluating technical tradeoffs while balancing cross-functional stakeholder needs.
Key Responsibilities
- Develop, document, and manage system and subsystem requirements in compliance with IVD and medical device regulations
- Ensure requirements traceability through verification and validation activities
- Perform risk management activities, including FMEA and mitigation planning
- Support system architecture design and implementation to meet product and regulatory requirements
- Plan and support verification and validation strategies, protocols, and reporting
- Collaborate cross-functionally with assay development, R&D, quality, regulatory, and other stakeholders
- Facilitate technical discussions and decision-making, balancing competing priorities and tradeoffs
- Maintain configuration management and documentation best practices throughout the development lifecycle
Required Qualifications (Must Have)
- 3–5 years of experience in systems engineering or related roles within a regulated industry (medical device preferred)
- Demonstrated experience writing and managing requirements in a regulated environment
- Hands-on experience conducting risk analysis (e.g., FMEA) in an engineering discipline
- Strong understanding of systems engineering principles, including:
- Requirements engineering
- Tradeoff analysis
- Risk management
- Configuration management
- Verification and validation
- Proven ability to work cross-functionally and align multiple stakeholder needs
Preferred Qualifications (Ideal)
- Assay development experience, particularly with cytology specimens
- Experience working with RETINA (Requirements & Test Integration Application)
- Familiarity with LucidSpark and/or LucidChart
- Strong organizational and prioritization skills with the ability to manage multiple projects simultaneously
Why Join
This role offers the opportunity to work on impactful diagnostic technologies while applying rigorous systems engineering practices in a collaborative R&D environment.
#WCH
Job Type: Contract
Pay: $42.00 - $45.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Application Question(s):
- How many years of experience working in a regulated industry?
Experience:
- Risk Management & FMEA: 3 years (Required)
- Assay Development: 3 years (Required)
- Documentation: 3 years (Required)
- Systems engineering: 3 years (Required)
Work Location: In person
