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Senior Quality Engineer, Electro-Mechanical Systems
Job#: 17QA-03
Positions: 1
Posted: 03/12/2018
Job Type: Full Time
Location: Danvers, MA
Department: Quality
Salary: Commensurate with Experience
Contact: Tim Donahue
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Job Description

Does the idea of ensuring the quality of life-saving electro-mechanical devices appeal to you? Do you consider yourself an IEC 60601 expert? Would you be excited to contribute to industry-leading Class III medical device quality standards at one of the fastest-growing companies in the world? If so, consider the following opportunity.

This Senior Quality Engineer will be the subject matter expert for Abiomed’s main intelligent electro-mechanical control system, the “AIC”. As the lead quality engineer you will be responsible for driving quality-related engineering initiatives for new product development and product improvements, the risk evaluation and mitigation process and planning, assessment of software development and the testing processes and support of manufacturing and field service where appropriate.


  • Responsible for strategically developing and finally executing quality and risk plans to ensure requirements are met during product development, product launch and throughout the full lifecycle
  • Insure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments
  • Work closely with electronics and software suppliers and various internal functional groups in areas of quality including process development and the corrective actions
  • Responsible for working with design assurance engineering in support of Abiomed’s Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports
  • Investigation and review of customer complaints, ensuring that root cause investigations are thorough and corrective / preventive actions are robust
  • Work with manufacturing engineering to ensure necessary process controls are in place
  • Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed
  • Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
  • Assess reliability growth strategies in both systems and software and provide input to the engineering teams


  • BS degree in a relevant Engineering discipline required (i.e., BSEE, CS); MS preferred
  • 10 years of experience in a Quality Engineering role in the medical device industry
  • Experience supporting the design and manufacture of intelligent electro-mechanical medical devices used in a critical care setting
  • Working knowledge of Electrical, Safety, EMC compatibility and software testing standards
  • Experience in reliability and reliability growth engineering for Electro-mechanical systems and software
  • Demonstrated experience with formal problem-solving methodologies and deductive skills
  • Strong statistical / data analysis skills (e.g., Minitab)
  • Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
  • Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
  • Ability to act independently to determine methods and procedures
  • Must be proficient in Microsoft Office Suite
  • Working knowledge of SAP desired


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