Share this Job

Sr. Design Quality Engineer - Software

Date:  Jan 8, 2021

Danvers, MA, US, 01923

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,500 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.


Patients First | Innovation | Winning Culture | Heart Recovery


This position is responsible for various quality engineering functions in support of development such as design assurance engineering activities, as well as manufacturing process development, and data/statistical trending with an emphasis on Medical Device software.


Primary Duties and Responsibilities:


The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position:

  • Support and Lead Design Assurance engineering activities in support of Abiomed’s Software Product Development and Software 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, post-market monitoring, investigations, follow-up and reporting
  • Insure that Design controls are compliant with  IEC 62304. 
  • Familiarity with TIR45 and Agile  methodologies.
  • Insure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments
  • 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 for design changes.
  • Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed
  • Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard
  • 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
  • Collect, analyze & report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
  • Develop statistically sound sampling plans and perform data analysis
  • Assess reliability growth strategies in both systems and software and provide input to the engineering teams

Job Qualifications:

  • Bachelor degree in Engineering or Sciences is required, Masters preferred
  • 5+ years of quality experience
  • Experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred
  • Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements
  • Takes initiative and demonstrates leadership and team work



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.

Nearest Major Market: Boston