Test Engineer Jobs

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

Abiomed is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enable positive people to do profoundly important work. The successful candidate will support engineering initiatives within the Access Engineering group (product development), with a focus on interventional cardiology devices and accessories. The role will demand hands on prototyping and testing, analysis and problem solving, and collaboration with the design team

Principal Duties and Responsibilities:

• Collaborate to ensure compliance with design controls, company quality policy and applicable regulatory requirements.
• Fabricate prototypes with assistance from technical support team (Machine Shop, Technicians and Designers) and suppliers.
• Analyze and report on test results, provide conclusions and recommendations. Perform failure investigations in the event of test failures with support from the technical team.
• Actively maintain storage of lab equipment and disposables and implement new solutions to increase lab efficiencies.
• Conduct feasibility and verification testing.
• Design and build test fixtures.
• Perform test method validations
• Prepare reviews and present to peers and review team.
• Effectively communicate activity status, issues, and mitigation plans with key stakeholders.
• Lead the development of new test methods.
• Author test plans, protocols, and summary reports.
• Coordinate procurement and installation of new lab and machine shop equipment
• Responsible for managing lab equipment preventative maintenance and calibration, coordinating with the internal and external calibration group
• Comply with documentation requirements of design control defined by ISO 13485.

Job Qualifications:

• 1-3 years of medical device engineering
• Experience applying statistical techniques and analysis in industry or education.
• Ability to adapt to changing workloads and priorities.
• Strong problem solving skills and experience identifying root cause of device failures.
• Well organized and meticulous individual
• Ability to operate laboratory equipment, such as microscopes, pipettes, and other specialized tools.
• Ability to stand or sit for extended periods of time.
• Ability to work with potentially hazardous materials while wearing personal protective equipment (PPE).
• Ability to lift and move heavy objects up to 50 pounds (e.g., equipment, supplies, and containers).
• Ability to execute tasks in a timely manner under minimal supervision. Willingness to learn the space of interventional cardiology including the devices and the clinical practice.
• BS in Mechanical, Biomedical Engineering or directly related scientific discipline

Preferred Qualifications:

• 3D modeling and 2D drawing experience with SolidWorks preferred.
• Knowledge of cath lab and/or cardiothoracic/vascular surgical environments
• Well organized and meticulous individual
• 5S or other Lean Manufacturing experience
• Medical Device product development experience
• Knowledge in medical device clinical use, design controls and regulating standards

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.