Expired

Senior Systems Design Engineer


Greater Boston
Permanent
Negotiable
Engineering
PR/534988_1740507724
Senior Systems Design Engineer

seeking a talented and motivated Systems Design Engineer to join our dynamic team. The successful candidate will be responsible for designing, developing, and optimizing complex medical device systems. This role requires a strong understanding of engineering principles, medical device regulations, and cross-functional collaboration.

Key Responsibilities:

  • Design and develop medical device systems, ensuring compliance with regulatory standards (e.g., FDA, ISO).
  • Collaborate with cross-functional teams, including mechanical, electrical, and software engineers, to integrate system components.
  • Conduct system-level analysis and testing to ensure performance, reliability, and safety.
  • Create and maintain detailed design documentation, including specifications, schematics, and test plans.
  • Participate in risk management activities, including FMEA and hazard analysis.
  • Support the verification and validation process, including test protocol development and execution.
  • Troubleshoot and resolve system-level issues during development and post-market phases.
  • Stay current with industry trends, technologies, and regulatory changes.

Qualifications:

  • Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related field.
  • 3+ years of experience in systems design, preferably in the medical device industry.
  • Strong knowledge of medical device regulations and standards (e.g., FDA, ISO 13485).
  • Proficiency in systems engineering tools and methodologies (e.g., SysML, MATLAB, Simulink).
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and teamwork abilities.
  • Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications:

  • Experience with embedded systems and software development.
  • Knowledge of human factors engineering and usability testing.
  • Familiarity with quality management systems (QMS) and design control processes.

FAQs

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