Engineer II

Title: Systems Engineer II

Duration : 12 Months

Location : Irvine, CA



Job Description
The client is looking for a Systems Engineer II/III (contractor) to join their 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.

Roles and Responsibilities

• Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.

• You will be responsible for working across engineering teams to lead and drive the following: 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.

• Strong organizational, facilitation, and communication skills with the ability to influence across a matrixed organization and manage competing priorities.

• Support in contributing to broadening the understanding and implementation of appropriate systems engineering principles within Client.
• You will be responsible for providing technical leadership in your areas of responsibility and ensure the systems design and documentation meet all safety and regulatory compliance requirement.

• Strong analytical and decision-making skills; self-driven and proactive in approach.

Qualifications

• Bachelor's Degree or equivalent education and typically 5-10 years of experience, Master's Degree or equivalent education and typically 3-7 years of experience, PhD and typically 1-4 years of experience; depending on the title Systems Engineer II or Systems Engineer III.
• Possess thorough theoretical and practical understanding of own scientific discipline.
• Effective writer and communicator of research or other regulatory materials.
• Leadership experience is required that includes the ability to influence and negotiate internally and externally.
• Product development experience in regulated industry (like Medical Device, Pharma & Biotech) required.
• Expertise in design and development processes that conform to standards including IEC 60601, ISO 14971, IEC 62304, 11608, 11040, and the ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and MDR.
• Experience is required in user and stakeholder need definition; requirements definition; risk management, product architecture.
• Other attributes include strong analytical, decision making and communication (spoken and written) skills. It is expected that you will create and manage project schedules and help identify project risks and develop mitigation plans.