About Sterling Medical Devices:
Sterling Medical Devices, a provider of custom electro-mechanical and software solutions for the medical device industry, has been dedicated to helping our clients resolve medical device development challenges. Our engineering teams address the whole development process: systems, software, electronics, mechanical, quality, and compliance. Our headquarters, located in Moonachie, NJ, is a casual work environment that engages our team in cutting edge technologies and projects.
Sterling has over 20 years of experience working with doctors, startups, medical device companies and providing solutions for healthcare companies that need to scale up quickly to bring medical device software, hardware, mechanical, and mobile medical device apps to market by successfully navigating the FDA and CE approval process. We design our client’s products with a focus on the user needs and requirements, while making smart design choices based on our extensive and diverse product development experience.
We are currently searching for a Test Engineer to join our team. This position will be responsible for working closely with a development team to document, analyze, create and test systems including both software and hardware aspects for state of the art medical devices. The ideal candidate is a self-starter with a passion for being part of a team developing medical technologies that improve people’s lives.
Essential Duties and Responsibilities:
- Create and update project documentation such as requirements (software, hardware, and system), traceability matrices, test plans, protocols and reports
- Apply systems analysis techniques and procedures, including consulting with clients, to determine and create hardware, software and/or system functional requirement specifications
- Interface with client, project lead, software and hardware design engineers to ensure that key system level features function as expected
- Create, execute and document formal verification testing (software, hardware, and system) on state of the art medical devices (embedded real-time systems, PC based systems, smartphone based systems, and Web based systems)
- Perform black box integration, system, and regression testing
- Trace effectiveness of verification activities based on traceability matrices
- Utilize commercial off-the-shelf software test tools to support the design and development of medical devices
- Work with team on the development of risk analysis and FMEA documentation
- Work with team members to understand, profile, and estimate complexity for project deliverables
- Estimate effort and resources required for requirements and verification activities and actively work towards improving accuracy of personal estimates in comparison to actual work effort performed
Education and Experience:
- Bachelor’s Degree in Computer Engineering, Electrical Engineering, or Biomedical Engineering, or similar discipline
- 3-5 years’ experience in software and/or hardware testing
- Experience with the software development life cycle
- Experience with test equipment/test tool design and implementation including the appropriate levels of qualification
- Experience debugging using emulators and electronic test equipment
- Experience ad-hoc testing is a must
- Experience with medical device development under quality systems
- Experience with Source Code Management, Requirements Management, and Defect Tracking systems
- Experience with RTOS and embedded firmware programming techniques
- Experience providing written reports, test protocols, and engineering documentation for testing of medical devices
- Experience with black-box and white-box testing
- Experience with automated testing
- Knowledge of and ability to work within safety related quality process is a plus: FDA, FAA (DO-178B), DOD, etc.
- Experience with C++, C, Visual Basic, and assembly a plus
Knowledge and Skills:
- Ability to write requirement specifications and test plans and protocols are a must
- Good knowledge of ISO 13485/14971, 93/42/EEC, 90/385/EEC, EN45502, EN60601-1, EN61000
- Good knowledge of System Engineering principles, current technologies, and product test techniques
- Good written skills to document concise and detailed S/W and H/W defects
- Good verbal, written and interpersonal communication skills
- Good documentation skills and attention to detail
- Good ability to execute test protocols, log and track defects to closure, collaborate with team to resolve
- Good ability to analyze and resolve non-routine product, testing, and/or test equipment/tool issues using independent judgment
- Good ability to develop unit test protocol (not mandatory)
- Excellent analytical skills
- High level of initiative with ability to self-manage
- Strong interpersonal skills with ability to work both independently and as part of a team
- Excellent written and verbal communication skills
- Ability to perform white box/unit testing is a big plus
- Ability to diagnose and repair hardware issues is a big plus
Sterling Medical Devices (SMD) is an Equal Opportunity Employer. SMD does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.”
Local candidates only at this time, please. We do not offer relocation assistance.
No third-party candidates please.