Senior Manager, Systems Engineering
K-Recruiting
Ansprechpartner: Patrick Neubauer
Houston, USA
Medizin und PharmaSystems EngineeringKlinische SystemeElektrischer SystementwurfEmbedded SystemsEngineering ManagementSoftware SystemsSystem DesignSystemintegratorSystemmodellierungElektronische SystemeProject Engineering
Beschreibung
Position Title: Senior Manager, Systems Engineering
Reports to:
Senior Director, Neuromodulation Systems
Freelance project:
(1099) or W2 options available
Function:
Systems Engineering
Location:
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).
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
- 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.
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.
Travel Requirements:
Moderate travel may be required (up to 25%)