System Engineer

At-a-Glance:

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a System Engineer.

Position Type:

• Contract
• Remote
  
  
  

Required:

• 5-8 years of systems engineering experience in a regulated environment, preferably within the medical device industry.
• Demonstrated experience implementing and managing design controls across the product development lifecycle.
• Strong expertise in requirements management and traceability, linking user needs to design inputs, verification, and validation.
• In-depth knowledge of medical device regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
• Experience working in cross-functional engineering environments including hardware, software, quality, and regulatory teams.
• Strong written and verbal communication skills in English, with the ability to produce clear technical documentation.
• Excellent analytical, organizational, and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment.
  
  
  

Responsibilities:

• Lead and support design control activities to ensure compliance with regulatory standards including FDA 21 CFR 820 and ISO 13485.
• Establish and maintain end-to-end traceability from user needs through design inputs, verification, and validation throughout the product lifecycle.
• Collaborate with cross-functional teams to ensure user needs are translated into clear design requirements and validated in final product designs.
• Support and coordinate design verification and validation (V&V) activities, ensuring products meet defined specifications and regulatory expectations.
• Develop and maintain Design History Files (DHF) and other design control documentation in accordance with internal and regulatory requirements.
• Work closely with hardware, software, quality, and regulatory teams to ensure consistent implementation of design controls across development programs.
• Identify and implement process improvements in systems engineering, design controls, and traceability practices to enhance product development efficiency and compliance.
  
  
  

Get in Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at 201-478-6913 to learn more.

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