Test Engineer

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 :

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

Job Qualifications:

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

Preferred Qualifications:

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

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.