Technical Writer - Medical Devices Job at Sunrise Systems, Inc. in San Diego

Our client, a leading medical devices manufacturing company, is looking for a Technical Writer – Medical Devices. This is for an initial duration of 12 months and is located in San Diego, CA.

Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)

Job Summary:

• The Technical Writer will be responsible for developing, writing, and maintaining comprehensive technical documentation for our Class II medical devices.
• This role requires a detail-oriented professional with strong writing skills and a deep understanding of regulatory requirements.
• The ideal candidate will have extensive experience in the medical device industry and the ability to work effectively with cross-functional teams.

Qualifications:

• Experience working in a regulated industry such as medical devices or pharmaceuticals.
• Extensive experience with regulatory compliance processes. Strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines.
• Demonstrated ability to be highly collaborative with marketing, clinical, quality, and regulatory reviewers.
• Five or more years writing and editing hardware/software user guides (print and online) and other technical product documentation.
• Ability to effectively manage the delivery of prioritized tasks.
• Ability to demonstrate a high level of initiative to gather information for developing documentation.
• Ability to work independently with minimal supervision.
• Effective at thinking independently and solving problems with product core team members.
• Ability to work under compressed deadlines and must be able to deal with unresolved situations, frequent project changes, delays, or other events.
• Ability to handle multiple projects with excellent follow-up and project management skills.
• Familiarity with electro-mechanical concepts and software application usage.
• Experience in device labeling and/or packaging content development.
• Familiarity with large company engineering change control processes and Agile software development methodologies.
• Experience with SAP, Oracle, or similar enterprise resource planning (ERP) system is a plus.
• Experience in version control systems (VCS) such as, Perforce, Apache Subversion, Microsoft Team Foundation Server, or GitHub.
• Knowledge of photography and photo editing software such as Adobe Photoshop.
• Skilled in both electronic and hard copy markup (Acrobat, tracked changes in Microsoft Word, standard editorial and proofreading symbols).
• Knowledge and experience with desktop publishing (DTP) software applications (MadCap Flare, Adobe FrameMaker, Adobe InDesign, Adobe Illustrator, XML, DITA) as applicable for technical documentation.

Compensation: The hourly rate for this position is between $47-$50 per hour.

Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].