Job Description

Overview

The System Engineer will provide technical leadership and oversight for the development of new medical devices developed in conjunction with our clients customer partners in a fastpaced environment. The System Engineer will develop systems engineering deliverables such as requirements product architecture and risk analysis and be a key team member working closely with the customer s team. The ideal candidate will have a successful track record of leading technical product
development teams and launching products into production.

Job Responsibilities

• Requirements management and development
• System architecture definition including interface definition and interaction diagrams
• Risk Management including DFMEA
• Concept Development including evaluation and selection
• Technology / key component selection
• Oversee HW/SW integration
• Work with product verification team for test method development
• Participate in prototype build activities
• Root cause investigation of technical issues
• Be customer facing and interface with the customer s technical team

Required Expertise

• Solid critical thinking and decisionmaking skills
• Ability to work closely with the project manager and drive action within the team
• Clearly communicate complex information especially with the management team
• Knowledge of the medical device standards and regulations such as IEC 60601 or ISO 11608

Desired Skills

• Ecodesign techniques a plus
• Experience with using Modern Requirements or similar requirements management tools
• Experience with using APIS or similar DFMEA tools
• Experience with MatLab / Simulink
• Manufacturing process development

Education and Work History Requirements

• BS in ME EE SW or Biomedical engineering is required
• At least 10 years of relevant experience in medical device development
• Experience managing entire design cycles from concept to production

Required Skills : Professional EngineerMedical Device

Basic Qualification :

Additional Skills :

Background Check : No

Drug Screen : No

Job Tags

Similar Jobs