Title: 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.
- Provide 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.
Requirements:
- 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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