Job Description

Job description:

The System Engineer will provide technical leadership and oversight for the development of new medical devices developed in conjunction with our client's customer partners in a fast-paced 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 decision-making 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

• Eco-design 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

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