Systems Engineer II/III

Target PR Range: $39–$49/hr DOE

About the role

We are looking for a Systems Engineer II/III (contractor) to join our Device and Combination Product Development – R&D team. This individual will contribute to the development and launch of exciting new drug/device combination products. As a Systems Engineer, you will be responsible for the integration of multiple disciplines to ensure robust patient-centric product design and performance.

Responsibilities

• Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
• Lead and drive cross-engineering-team activities: User and Stakeholder Needs Definition, Use Case Analysis, traceability, Standards Coverage Analysis, System/Sub-System Requirements Definition, integration of third-party development activities, System Architecture & integration, Risk Management Planning and reporting, System Risk Assessment, Use Error Risk assessments, integration of drug product development activities, and design validation.
• Provide technical leadership to ensure systems design and documentation meet all safety and regulatory compliance requirements.
• Support broadening the understanding and implementation of appropriate systems engineering principles within the organization.
• Create and manage project schedules, identify project risks, and develop mitigation plans.
• Demonstrate strong organizational, facilitation, and communication skills with the ability to influence across a matrixed organization and manage competing priorities.
• Apply strong analytical and decision-making skills in a self-driven, proactive manner.

Requirements

• Bachelor’s Degree or equivalent education and typically 5–10 years of experience (Systems Engineer II) or Master’s Degree or equivalent education and typically 3–7 years of experience, or PhD and typically 1–4 years of experience (Systems Engineer III).
• Thorough theoretical and practical understanding of your scientific discipline.
• Leadership experience, including the ability to influence and negotiate internally and externally.
• Product development experience in a regulated industry (e.g., Medical Device, Pharma & Biotech).
• Expertise in design and development processes conforming to standards including IEC 60601, ISO 14971, IEC 62304, 11608, 11040, and ability to work in a regulated environment compliant with ISO 13485, 21 CFR 820, and MDR.
• Experience in user and stakeholder need definition, requirements definition, risk management, and product architecture.
• Strong analytical, decision-making, and communication (spoken and written) skills.
• Effective writer and communicator of research or other regulatory materials.