The Quality Engineer will be responsible for Quality Engineering activities associated with all electro-mechanical and hardware/software based Abiomed products and processes.
Principle Duties and Responsibilities:
Provide Quality Engineering support in the design, development, market release and post market release of intelligent control systems for the Abiomed product line (Product Specifications, Risk Assessments, V&V, etc.)
Investigation and review of customer complaints of these systems, 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
Represent Quality Assurance on Product Development Teams, Engineering Change Orders (ECO) and Material Review Board (MRB)
Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA…), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standards
Participate and drive the test planning based on risk for electro-mechanical systems (includes EMI/RFI, electrical safety and software)
Participate selectively in both Internal and/or External supplier audits
Skills/Requirements
Job Qualifications:
BS in Engineering in a relevant discipline (BSEE, CS or Biomedical systems e.g.); MS preferred
2 years minimum of experience in a Quality Engineering role in the medical device field
Demonstrated experience with formal problem-solving methodologies and deductive skills
Experience supporting the design and manufacture of medical device electronics
Independent thinker and team player
Experience designing electromechanical systems (implantable, consumable, disposable) medical devices is a plus
Clinical/field experience with cardiac devices is a plus
Strong statistical / data analysis skills (e.g., Minitab)
Six Sigma knowledge and/or demonstrated practical statistics knowledge is a plus
Ability to Communicate ideas and information clearly, effectively and frequently (oral and written)
Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results
Execute tasks in a timely manner without direct supervision; Able to prioritize tasks
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.
