Technical Writer 2
Abiomed, part of the Johnson & Johnson Family of Companies is recruiting for a Technical Writer 2 to be located in Danvers, MA.
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
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 Du ti es and Responsibili ti es :
- 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 Quali fi ca ti ons:
- 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 QMS desired.
- Willing & able to travel internationally (~5%)
Preferred Quali fi ca ti ons:
- 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.