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Technical Writer II

Date:  Sep 7, 2022
Location: 

Danvers, Massachusetts, 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, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 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
 

Patients First | Innovation | Winning Culture | Heart Recovery

 

ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work. If you have: a forward-thinking approach to technical writing, the technical background to write best-in-class documentation and procedures, and the desire to make a true impact Manufacturing team regarding documentation of manufacturing processes then we want to hear from you. Discover your true potential as you support Manufacturing with engineering change orders (ECO), work instructions (WI), job instruction breakdowns (JIBs), training documentation, creating and editing of short videos to support technical procedures. This position will also support the engineering team on validation protocols and reports. The ideal candidate will be: goal-oriented and data-driven; detail oriented; and experienced in content development/management.

 

Principle Duties and Responsibilities:

  • Develop and update process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.
  • Work with the training team to develop short videos that can supplement hands on training.
  • Ability to work in cross-functional teams that span global operations. Proficient in English verbal and written communication. Ability to translate WI and JIBs to and from to German or work with a translator is necessary.
  • Must enjoy team approach over individual contributions. Ability to be a liaison with manufacturing assemblers and engineering teams to develop and edit work instructions and assembly documentation.
  • Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations. Knowledge of FDA QSR and ISO regulations required.
  • Regularly report on project status, schedule progress and key project metrics through scorecard presentations
  • Assist engineering team to qualify and optimize processes and tooling via documentation for IQ/OQ/PQ, preventive maintenance, Gage R&R Studies, Process Capability Studies and Designs of Experiments.
  • Participate in the implementation of internal corrective actions and audit findings
  • Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments related to company products.

 

Job Qualifications:

  • Bachelors required in life sciences and/or writing, medical device experience preferred.
  • 2+ years of technical documentation experience
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team
  • Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired.
  • Willing & able to travel internationally (~5%)

 

Preferred Qualifications:

  • Medical device experience
  • Knowledge of FDA QSR and ISO regulations
  • Working knowledge of SAP

 

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.


Nearest Major Market: Boston