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Senior Quality Electrical Engineer
Job#: 17QA-03
Positions: 1
Posted: 05/25/2017
Job Type: Full Time
Location: Danvers, MA
Department: Quality
Salary: Commensurate with Experience
Contact: Tim Donahue
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Job Description

The Senior or Principal 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.

Primary Duties and Responsibilities:

  • 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
Skills/Requirements

Job Qualifications:

  • 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

ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.  We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.
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Fraudulent Job Offer Information

ABIOMED is aware that some job seekers have received false employment offers or recruitment emails from an individual or organization posing as ABIOMED. Individuals or organizations sending these false employment offers may request personal information or funds to further the recruitment process.

Please be aware that ABIOMED will never request passport details, money or other personal or financial information from job seekers. All individuals who are successful in gaining an offer of employment from ABIOMED, whether directly or indirectly, are always required to go through a formal recruitment process including an interview with a member of ABIOMEDís recruitment team.

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