Technical Writer

Shift: 1st Shift, Monday-Friday
Duration: 09 Months
Pay range: $48.00 Hourly - $48.00 Hourly
Hybrid role business hours

• We are looking for innovative candidates to be a key contributor in supporting the development of software product that impact on patient lives.
• The candidate will support R&D with primary responsibility for the hands‑on management of documentation supporting software diagnostics product development and on‑market product improvements.
• This candidate will work closely with cross‑functional teams to write, edit, review and finalize technical documents required for software products which includes but not limited to documents involving design control deliverables, verification and validation protocols and reports, and other documents associated with the phase‑gate development of new products and the transfer of products from R&D to production.
• This technical writer role will be a trusted resource and a key core team member in a multi‑functional, multi‑site project team.
• This position will be responsible for developing the documents for the software application according to IEC 62304 and 21 CFR Part 11 environment.

• Follow design control for new software product development per FDA and international guidelines
• Build Design History File for new software product development
• Develop design control documentation, including Design and Development Plans, Development Reports, Test Method and Process Validation Protocols, FMEAs
• Manage document change control
• Develop Standard Operating Procedures
• Maintain integrity of documents to comply with and be incorporated into the company's quality procedures. High quality, well formatted, clear documentation following GDP (good documentation practices) is mandatory.
• Development of customer‑facing documentation e.g. user guides, training manuals
• Solicit, align, and incorporate feedback from diverse stakeholders.

Bachelors in related field plus 5 years of experience

• Excellent verbal and written communication skills
• Skills in Microsoft Office
• Ability to work in a fast paced environment
• Ability to drive project progress per assigned task
• Must be highly collaborative, have the ability to work within a diverse team, and contribute to a supportive, positive work environment both within the team and in the greater site‑wide community
• Knowledge of FDA regulations for software product development
• Translates software user needs

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

Lance Soft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross‑culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias.

We provide Global Workforce Solutions with a human touch.