• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Title: Technical Writer- Medical Device
Location: Danvers MA
Duration: 6 Months +
Interview: Phone and Face to Face

Job description:

· Important Skills Technical Writer – This role is to perform all the write up for formal verification and validation testing. This includes, plans, protocols, reports, and engineering summaries, and IQOQ’s. Engineering background in preferred as they might be pulled into the lab to help support some mechanical testing if needed.

Principle Duties and Responsibilities:

• Develop and update process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.

• Assist engineering team to qualify and optimize processes and tooling via IQ/OQ/PQ, preventive maintenance, Gage R&R Studies, Process Capability Studies and

• Designs of Experiments.

• Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments

• related to company products.

• Ability to work in cross-functional teams that span global operations. Proficient in English and German verbal and written communication. Must enjoy team

• approach over individual contributions.

• Regularly report on project status and schedule progress

Job Qualifications:

• Bachelors required in life sciences and/or writing, medical device experience preferred.

• 2 to 5 years related Engineering experience required

• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.

• Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired.

All your information will be kept confidential according to EEO guidelines.