Job Description

Title:  Test & Reliability Engineer

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 the product 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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Job Tags

Permanent employment, Immediate start,

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