Systems Engineer II

Description

We are looking for a Systems Engineer to be responsible for the coordination and management of system design across one or more related product programs. This role supports both new product development and the maintenance of existing products, ensuring alignment with program goals, regulatory requirements, and market needs.

The role will partner cross-functionally with Marketing, Sales, Service, Operations, Quality Assurance, and Regulatory Affairs to define requirements, communicate technical direction, and resolve product-related issues throughout the product lifecycle.

Key Responsibilities:

Lead the end-to-end product development lifecycle from user needs definition through product launch.

Partner with Engineering Project Management to scope and define projects aligned to program goals.

Translate market and customer needs into clear, actionable technical requirements.

Own and maintain the Design History File (DHF), ensuring completeness and compliance.

Develop system-level specifications and ensure proper decomposition into subsystem requirements.

Lead risk management activities in accordance with IEC 14971.

Ensure usability requirements are addressed in compliance with IEC 62366.

Create and manage Verification and Validation (V& V) plans to support product traceability.

Ensure traceability between requirements, design, and verification activities.

Lead system architecture development, including interface and subsystem specifications.

Provide technical leadership to cross-functional development teams.

Resolve competing priorities across engineering, manufacturing, regulatory, and commercial teams.

Lead system integration efforts and proactively identify and mitigate integration risks.

Apply structured problem-solving tools (e.g., root cause analysis, Pareto analysis) to resolve technical issues.

Ensure product designs consider manufacturability, serviceability, and performance requirements.

Support technical documentation and collaborate with technical writing teams for user-facing materials.

Requirements

Core Qualifications:

Bachelor's degree in Electrical, Mechanical, Software, Biomedical Engineering, or related field (or equivalent experience).

3+ years of experience in systems engineering or product development.

Proven experience in system development including requirements and risk management, usability engineering, performance and reliability engineering, and cybersecurity considerations.

Hands-on experience with product development tools/methodologies (QFD, Pugh Matrix, CTQ, DFR, DFX).

Experience leading or contributing to system architecture and design efforts.

Strong understanding of design controls and documentation (DHF ownership, traceability, V& V).

Excellent communication, leadership, and cross-functional collaboration skills.

Strong organizational skills and ability to manage multiple priorities.

Ability to work independently and drive tasks to completion with minimal supervision.

Proficiency in Microsoft Office tools.

Strong problem-solving and analytical skills.

Preferred Qualifications:

Experience in medical device development (diagnostic cardiology or similar strongly preferred).

Familiarity with industry standards such as IEC 62366 (Usability) and IEC 14971 (Risk Management).

Agile product development experience.

Experience with system integration and complex product architectures.

Demonstrated ability to influence stakeholders and drive technical decisions.

Experience supporting regulatory submissions and quality audits.

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