Staff Systems Architect - Medical Device Platform

Werfen; Bedford (MA); Presencial; USD 205.000 - 245.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Paid vacation and sick leave

Descripción de la vacante

Werfen seeks a Staff Systems Architect to lead the design of next‑gen Hemostasis products. You will shape architecture across hardware, software, and reagents, aligning cross‑functional teams and regulatory requirements.

Ideal candidates bring deep IVD/system engineering experience, risk management skills, and a track record of delivering complex medical devices from concept to commercialization.

Formación

• Master's degree in Engineering or equivalent with 12+ years experience.
• Proven track record leading products from concept through commercialization.
• Expertise in medical device hardware, interfaces, and system architecture.

Responsabilidades

• Lead system architecture and technical strategy for complex medical devices and IVD platforms.
• Translate needs into system requirements, workflows, interfaces and verification plans.
• Drive cross-functional decisions, risk assessment, and design reviews across disciplines.
• Define integration, verification, validation and reliability strategies per regulations.
• Govern architecture docs, baselines, interfaces, and changes through config management.
• Mentor teams and promote best practices in system engineering.

Conocimientos

Systems architecture

Hardware design

Regulatory compliance

Risk management

SDLC & cybersecurity

Educación

Master's Degree in Engineering

12+ years experience

Herramientas

INCOSE

IEC 62304

ISO 13485

Descripción del empleo

Werfen seeks a Staff Systems Architect to lead the design of next‑gen Hemostasis products. You will shape architecture across hardware, software, and reagents, aligning cross‑functional teams and regulatory requirements.

Ideal candidates bring deep IVD/system engineering experience, risk management skills, and a track record of delivering complex medical devices from concept to commercialization.