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Test & Reliability Engineer

System One
Santa Monica, CA Full Time
POSTED ON 1/15/2025
AVAILABLE BEFORE 3/28/2025

Title : Test & Reliability Engineer

Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below.

Location : Onsite- Philadelphia, PA

Schedule : M-F 9 : 00 am-5 : 00 pm

Type : Direct-Hire / Permanent

Start : Immediately

Overview :

Our client, an innovative startup in the medical device industry, is seeking a Test & Reliability Engineer to assist in developing groundbreaking technology. In this hands-on role, you'll lead verification testing, enhance system reliability, and contribute to FDA submissions. If you're an experienced engineer with a passion for making a real impact in healthcare we’d love to hear from you!

Responsibilities :

  • Develop protocols and lead the Verification testing effort for theproduct line.
  • Drive evaluation and improvements of the system for reliability.
  • Lead the production of test documentation to support FDA submissions
  • Plan and support IEC 60601 safety requirements.
  • Collaborate with cross-functional teams, including clinical, human factors, mechanical engineering, regulatory affairs, quality, manufacturing, and vendors, to ensure successful product development and launch.
  • Providing guidance and support to enhance the testing skills of engineering staff.
  • Stay current with industry trends, technologies, and regulatory changes, and incorporate this knowledge into the engineering strategy.

Qualifications :

  • Bachelor’s degree in Mechanical, Industrial, or Electrical Engineering, or related field.
  • 5 years of experience in test / Reliability engineering within the medical device industry.
  • Experience writing test protocols for medical devices.
  • Strong knowledge and hands-on experience with standard testing procedures.
  • Proven track record of successfully leading engineering testing projects.
  • Excellent problem-solving, time management / prioritization skills and willing to work on diverse projects.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively across all levels of the organization.
  • Experience using test equipment (oscilloscope, VOM, thermocouples, thermistors, flow sensors).
  • Familiarity with regulatory submissions and standards applicable to medical devices (e.g., FDA 21 CFR 820.30 and ISO 13485).
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