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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System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.