Description

Key Responsibilities

Lead systems engineering activities across various stages of the product lifecycle, from concept development through post-market support.

Gather, analyze, and manage system requirements from clinical, regulatory, manufacturing, quality, service, and stakeholder inputs.

Translate user and business needs into system-level requirements and design solutions.

Develop and maintain requirements traceability and Design History File (DHF) documentation.

Support system architecture, integration, verification, and validation activities.

Conduct product risk assessments and contribute to risk mitigation planning and execution.

Perform impact analyses for design, process, material, and product changes.

Identify, investigate, and resolve complex technical issues using structured problem-solving methodologies.

Collaborate with cross-functional teams including software, electrical, mechanical, quality, regulatory, and manufacturing stakeholders.

Ensure compliance with applicable regulatory standards, design controls, and quality requirements.

Support technical reviews and contribute to continuous product and process improvements.

Influence project stakeholders and provide technical recommendations to support project objectives.

Required Qualifications

Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, Engineering Science, or a related technical field.

3+ years of experience in Systems Engineering or product development environments.

Strong understanding of systems engineering principles, requirements management, and product development processes.

Experience working with electro-mechanical systems and software-enabled products.

Knowledge of requirements management and systems modeling methodologies such as SysML or UML.

Strong analytical, troubleshooting, and problem-solving skills.

Excellent communication, collaboration, and stakeholder-management abilities.

Ability to work independently while managing multiple priorities in a fast-paced environment.

Preferred Qualifications

Experience in medical device development or other highly regulated industries such as aerospace, automotive, or defense.

Familiarity with connected devices, cybersecurity concepts, and software-integrated systems.

Experience with requirements and lifecycle management tools such as DOORS, Jama, Teamcenter, TrackWise, JIRA, or ALM.

Knowledge of design verification methodologies, statistical analysis, DOE, and sample-size determination.

Experience supporting design controls, risk management, verification, and validation activities.

Demonstrated success working within cross-functional and global engineering teams.

Key Skills

Systems Engineering

Requirements Management

Risk Management

Design Controls

Verification & Validation (V&V)

Product Lifecycle Management

Root Cause Analysis

SysML / UML

Cross-Functional Collaboration

Technical Documentation

Regulatory Compliance

Problem Solving

Key Skills

Education

Bachelor's or Master's degrees