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:

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

Requirements:

1. Bachelor’s degree in Mechanical, Industrial, or Electrical Engineering, or related field.
2. 5+ years of experience in test/Reliability engineering within the medical device industry.
3. Experience writing test protocols for medical devices.
4. Strong knowledge and hands-on experience with standard testing procedures.
5. Proven track record of successfully leading engineering testing projects.
6. Excellent problem-solving, time management/prioritization skills and willing to work on diverse projects.
7. Strong communication and interpersonal skills, with the ability to collaborate effectively across all levels of the organization.
8. Experience using test equipment (oscilloscope, VOM, thermocouples, thermistors, flow sensors).
9. Familiarity with regulatory submissions and standards applicable to medical devices (e.g., FDA 21 CFR 820.30 and ISO 13485).