Lead Medical Device Technical Writer - Fremont, United States - Ledgent Technology

Description

Medical Device client is seeking a Lead R&D Technical Writing Analyst - Hybrid in Fremont, CA

Pay Rate Range: $60.00/hr. - $73.33/hr.

12+month contract

Description/Comment:

As part of Sustaining R&D, the Lead Analyst, R&D Technical Writing is responsible for creating end-user regulatory complaint product labeling. The specialist contributes to new product development and design change (sustaining) activities in the areas of labeling design/release, technical writing, translation management, development of artwork/images and development or improvement of processes for improved efficiency and compliance. This role will engage with cross functional teams to resolve obstacles effectively, be responsible for meeting key labeling objectives, and lead/collaborate on continuous improvement initiatives or special activities having business impact.

General Requirements:

4-6 years of relevant experience in developing or delivery of technical publications that are part of products including writing, graphic design, development of artwork/images, document control, related to engineering, with part of experience in a medical device/regulated industry:

Bachelor's Degree in Graphics or Language or equivalent experience (Advanced degree may be considered towards years of experience)

Required to have a high level of service and responsibility in managing highly detailed and varied workload from internal customers and be comfortable working to tight timelines

Provide weekly summary of activities, create project plans, prioritize, and effectively communicate updates to customers

Follow Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training for incumbent position

Subject Matter Expert (SME) in Microsoft Applications (Word, Excel, PowerPoint, and Visio), Adobe Suite (InDesign, FrameMaker, Photoshop, and Illustrator)

Demonstrated experience in the following: Instructions for Use, Training Guides, Support of Electronic IFU (eIFU) and website, Translation management

Required Software:

Microsoft applications (Word, Excel, PowerPoint, and Visio)

Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator)

Experience in website design and testing

Nice to have Software:

For Label Designer Role: Database driven labeling system such as Prisym ID, Label View, Loftware, Bartender Nice Label, and Easy Label, Computer Aided Drafting (CAD) - Solidworks, AutoCAD

Additional Job Details:

Essential Duties & Responsibilities (detailed description):

Strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes

Leads structured problem-solving initiatives to resolve complex technical issues and document within appropriate quality system documentation

Drives creation of training and communication materials that can be used by self or other staff to convey new or updated processes.

As regulations change and quality systems are merged/aligned, execute the creation/refinement of department and quality system SOPs, Work Instructions, forms, and templates that have considerable graphical content with minimal supervision

Researches and builds knowledge about products, service, technology, test method and documents in the clearest, most logical way for greatest reader comprehension

Fully support the Quality Policy by building quality into all aspects by maintaining compliance to all quality requirements and supporting improvements that make it easier for the organization to maintain compliance in complex areas

Prepare for internal and external audits by gathering records, supporting backroom, and providing explanation for design areas developed by self with auditor in the Front Room

Lead recertification and other compliance projects by managing key activities with stakeholders to execute required changes and sometimes determine alternate design directions

Demonstrated extensive application of knowledge through delivery of high-quality deliverables (SOPs, technical literature and Work Instructions, engineering work product) to ensure continuity of content style that meets applicable standards and is appropriate for its intended audience

Provides input to creation of training and communication materials that can be used by self or other staff to convey new or updated processes

Experienced in modifying existing and creating new Quality System documentation (work instructions, standing operating procedures, forms, checklists, and templates)

Drives continuous improvement (NCs and CAPAs) and assessment of current procedures, generation of quality plans and identification of best practices

Advocates for creation or change in procedures and with complementary procedures owned by others, along with appropriate technical rationale to support recommended changes.

Contributes to process improvements to and drives key areas of strategic programs that implement improved processes to reduce error rates.

All qualified applicants will receive consideration for employment without regard torace, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status.We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.