Technical Writer - Abiomed

Johnson & Johnson - Danvers, MA

Full-time - Mid Level

Danvers, MA

Chemical Manufacturing

About the position

Johnson & Johnson is currently seeking a Technical Writer to join our Quality department located in Danvers, MA. This role is open to a hybrid schedule, allowing for a blend of in-office and remote work. The Technical Writer will play a crucial role in developing and updating process documentation, which includes assembly procedures, test procedures, routers, travelers, Bills of Materials (BOMs), process flows, and process Failure Mode and Effects Analyses (FMEAs). This position requires collaboration with the training team to create short videos that can enhance hands-on training for employees. The ideal candidate will have the ability to work effectively in cross-functional teams that span global operations. Proficiency in English, both verbal and written, is essential, and the ability to translate Work Instructions (WI) and Job Instruction Bulletins (JIBs) to and from German, or to work with a translator, is necessary. The Technical Writer must enjoy a team-oriented approach over individual contributions and will act as a liaison between manufacturing assemblers and engineering teams to develop and edit work instructions and assembly documentation. In this role, the Technical Writer will support and implement company goals and objectives, policies and procedures, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), as well as FDA Quality System Regulations (QSR) and ISO regulations. Knowledge of FDA QSR and ISO regulations is required. The Technical Writer will regularly report on project status, schedule progress, and key project metrics through scorecard presentations. Additionally, they will assist the engineering team in qualifying and optimizing processes and tooling via documentation for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), preventive maintenance, Gage Repeatability and Reproducibility (Gage R&R) Studies, Process Capability Studies, and Designs of Experiments (DOE). The Technical Writer will also participate in the implementation of internal corrective actions and audit findings, maintaining accurate documentation of concepts, designs, and processes while keeping current knowledge of medical, technical, and biomedical developments related to the company’s products.

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.
• Collaborate in cross-functional teams that span global operations.
• Translate WI and JIBs to and from German or work with a translator as necessary.
• Act as a liaison with manufacturing assemblers and engineering teams to develop and edit work instructions and assembly documentation.
• Support and implement company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
• 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 keeping current knowledge of medical, technical, and biomedical developments related to company products.

Requirements

• Bachelor's degree 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.
• Proficient in Microsoft Office Suite; working knowledge of Quality Management Systems (QMS) desired.
• Willing and able to travel internationally (~5%).

Nice-to-haves

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