Engineer II

Spectraforce Technologies; Irvine (CA); On-site; USD 83,000 - 124,000; Full time

Job summary

Spectraforce Technologies is seeking a Systems Engineer II/III for a 12-month contract in Irvine, CA. The role focuses on developing and launching drug/device combination products, integrating multiple disciplines to ensure patient-centric design and performance.

You will lead design controls, DHF management, and cross-functional activities to drive requirements, risk assessment, system architecture, and validation in a regulated environment.

Qualifications

• Bachelor’s degree in a relevant field with significant experience.
• 5–10 years of systems engineering experience for II/III level, depending on title.
• Experience in regulated industries (Medical Device, Pharma, Biotech).
• Expertise in design and development processes conforming to IEC 60601, ISO 14971, IEC 62304, 11608, 11040, and ISO 13485/21 CFR 820/MDR.

Responsibilities

• Lead DHF management and design control documentation in compliance with regulations.
• Coordinate across engineering teams to define needs, use cases, requirements, risk management, and system integration.
• Provide technical leadership and ensure designs meet safety and regulatory requirements.
• Create and manage project schedules and identify risks with mitigation plans.

Skills

Leadership

Regulatory knowledge

Systems engineering

Risk management

Communication

Project management

Stakeholder management

Education

Bachelor’s degree

Master’s degree

PhD

Job description

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.