Staff R&D Engineer, Medical Devices — Lead & Design

EBR Systems, Inc.; Milano; In loco; EUR 133.000 - 161.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

401(k) matching

Paid Time Off

Employee stock options

Education assistance

Commuter benefits

Weekly company lunches

Descrizione del lavoro

EBR Systems, Inc. is seeking a Staff R&D Engineer to lead product development from concept through design transfer, combining mechanical/biomedical engineering with rigorous project execution.

The role requires driving plans, managing critical paths, mitigating risks, and ensuring compliance with FDA/ISO design controls. It offers growth in a fast-moving startup culture with competitive compensation and comprehensive benefits.

Competenze

• BS degree in mechanical, biomedical, or related engineering.
• 8+ years of progressively complex engineering and product development experience.
• Knowledge of medical device regulations and standards (FDA, ISO 13485, ISO 14971).
• Strong project management skills and ability to lead cross-functional teams.

Mansioni

• Lead and manage product development projects from concept through design transfer in accordance with design controls.
• Develop and manage project plans, timelines, milestones, deliverables, dependencies, and critical path to drive timely execution.
• Identify project risks and barriers, develop mitigation strategies, and drive resolution across engineering and cross-functional teams.
• Ensure complete traceability from design inputs through design outputs and verification and validation.

Conoscenze

Project management

Medical devices

Design controls

Risk management

V&V

SolidWorks

Regulatory knowledge

Cross-functional teams

Formazione

BS degree in mechanical, biomedical, or related engineering

Strumenti

SolidWorks

Microsoft Office

Descrizione del lavoro

EBR Systems, Inc. is seeking a Staff R&D Engineer to lead product development from concept through design transfer, combining mechanical/biomedical engineering with rigorous project execution.

The role requires driving plans, managing critical paths, mitigating risks, and ensuring compliance with FDA/ISO design controls. It offers growth in a fast-moving startup culture with competitive compensation and comprehensive benefits.