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Staff Technical Writer, medical device hardware service doc, MS Word, onsite Fremont (SMD-603)

Summary: This promising medical device startup needs a Staff (or Contract-to-Staff) Technical Writer to write and publish accurate, clear, FDA- and CE-compliant customer product documentation

Job title: Staff Technical Writer, medical device hardware service doc, MS Word, onsite Fremont (SMD-603)
Job code: SMD-603
Compensation: Base salary of up to $110k plus pre-IPO stock options, and excellent employment benefits. If starting on contract, the hourly rate will be up to $65/hr 1099 (or $53/hr W2).
Location: Fully onsite, 40 hrs/week, Fremont (~5 miles from Fremont BART station)
Audience: Orthopedic surgeons and medical support staff (system operators, trainers, and service personnel)
Tasks: Use functional specifications, and your own use of medical equipment, in collaboration with Product Development, to acquire and analyze product information. Using MS Word, develop, release, and maintain product instructions and related content (see "Deliverables"). Also contribute to company webpage content, marketing collateral, clinical documentation, and internal plans, policies, and procedures. Apply company's style and operations guides to ensure consistency as well as FDA and CE regulatory compliance.
Deliverables: (1) Hardware user manuals, (2) service instructions, (3) quick-reference guides, (4) training materials, (5) instruction sheets, (6) product labeling, (7) hardware and software requirement specifications, (8) software design documents, and (9) regulatory submission documentation
Tools: MS Word, and a homegrown online help authoring tool
Soft Skills: Independently motivated, concerned with both the details and the big picture, and dedicated to user-centered document design
Team: Two senior-level staff Tech Writers and a contract Technical Writer. SMEs include Marketing, Hardware and Software Engineering, Customer Training, Clinical Applications, Quality Assurance, and Regulatory Affairs.
Starts: ASAP
Duration: Full-time, 40 hrs/week. If you start on contract, expect to convert to staff/salaried status within three (3) months.
Relo/Visa help: No
Representation: Principals only, please

Required:

  • Expertise in creating and maintaining highly usable and controllable end-user-friendly hardware documentation for a regulated industry
  • Proven ability to read and decipher specifications and blueprints, scope work, define project schedules, manage diverse stakeholders, build consensus, and independently drive deliverables to completion
  • Knowledge of Good Manufacturing Practices (GMP) and applicable quality system standards
  • Excellent oral and written communication, research, analytical, problem-solving, and interpersonal skills
  • Advanced proficiency with Microsoft Word
  • Shareable portfolio of clear procedures writing samples
  • Willingness and ability to work fully onsite in Fremont

Desired:

  • Degree in communications-related discipline, computer science, engineering, or life sciences
  • Work experience in the medical device industry writing or editing scientific material
  • Exposure to Visure Requirements
  • Familiarity with Adobe Creative Suite
  • Working knowledge of content management, online publishing tools, and spreadsheets
  • Illustration or diagramming experience
  • Knowledge of localization best practices and how to create content for a global audience

To apply:

Please email your Word-formatted resume (and a cover letter highlighting any relevant but less-than-obvious experience) to Andrew Davis, synergistech@gmail.com, citing "SMD-603" in your Subject line.

Technical Writer, Tech Writer, Documentation Writer, Information Developer, Content Developer, manual, procedures, documentation, policies, quality, regulations, regulatory, compliant, GMP, manufacturing, surgery, surgeon, medical, medical device, training, courseware, instructional design, course development, joint replacement, how-to, Visure Requirements, life sciences, lab sciences, blueprint, service doc, hardware, content management, Fremont, South Bay, Silicon Valley

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