Senior Manager, Systems Engineering

Project overview

Position Title: Senior Manager, Systems Engineering

Reports to:

Senior Director, Neuromodulation Systems

Freelance project:

(1099) or W2 options available

Function:

Systems Engineering

Requirements

Moderate travel may be required (up to 25%)

Project details

Houston, TX, USA

Note: Preference is Houston-based, with Hybrid in-office (3 days/week), but Remote is acceptable. In the case of remote, willingness to travel is important (quarterly).

Position Summary

Lead Systems Engineering, Risk Management and Design Control for the development and commercialization of complex medical devices. Drive system architecture, requirements, verification/validation and cross-functional engineering activities from development through product launch.

Key Responsibilities

Key Skills & Experience

Education:

Bachelor of Science (BS) or higher degree in an engineering discipline or equivalent.

Preferred degree in Systems Engineering, Biomedical Engineering, Clinical Engineering, Electrical Engineering, Software Engineering or equivalent.

Preferred certification in Systems Engineering (e.g., from INCOSE) or equivalent.

Advanced degree preferred.

• Lead and develop the Systems Engineering team and establish best practices.
• Own Systems Engineering, Risk Management and Design Control processes.
• Define system architecture, user needs, requirements, interfaces and traceability.
• Manage system risks and define appropriate risk control measures.
• Lead Design Verification & Validation (V&V) strategy, planning, execution and reporting.
• Collaborate with hardware, software and cross-functional teams.
• Support Change Control, Non-Conformance, CAPA and defect investigations.
• Ensure compliance with the QMS, regulatory requirements and applicable standards.
• Support technical documentation, registration activities and audits.
• Expert Systems Engineering, ideally INCOSE and/or MBSE.
• Expert Risk Management, including ISO 14971 and IEC 62366-1.
• Strong Design Control and Medical Device Development knowledge, including ISO 13485 and 21 CFR 820.30.
• Experience with requirements and risk management tools.
• Knowledge of software development, Agile/Scrum, IEC 62304 and cybersecurity.
• Experience with complex electro-mechanical-software systems preferred.
• Experience with active implantable / neuromodulation devices preferred.
• Strong leadership, communication and technical writing skills.
• Excellent English.
• Start: date 11/2026
• Duration: 6 months
• Remote: hybrid
• Location: Houston, USA, US