The Technical Writer will work under general supervision to develop, create, and/or edit operational, instructional, maintenance, inspection, test procedures and other documentation in support of the development and manufacture of medical devices.

KEY ROLE AND RESPONSIBILITIES:

• Research and document engineering processes, validation documentation, and specifications.
• Develop and update process documentation including assembly procedures, test procedures, BOMs, process flows, and process FMEAs.
• Collaborate openly and effectively with Engineering, Operations, Quality, and Supply Chain, among others, to ensure accuracy and completeness of content.
• Produce products that conform to the company documentation and Quality Management System (QMS) standards.
• Recommend formats responsive to technical, operational, quality, and customer requirements.
• Must possess strong written and verbal communication skills.
• Ability to multitask and prioritize to meet timelines and milestones.
• Be highly organized and attentive to details.
• Maintain design and development documentation to support quality and regulatory process requirements.
• Support and implement company goals and objectives, policies and procedures, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), FDA QSR and ISO regulations.

Minimum Qualifications:

• Bachelor’s degree in a technical area.
• Experience in technical communications, writing/ composition, or similar related field.
• Must be proficient in Microsoft Office Suite.
• Experience working with cross-functional project teams.


Physical Demands:
• The employee is occasionally required to sit; climb, balance, stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 50 pounds.

Work Environment:
• The employee may be required to work in a clean room environment and is expected to follow the guidelines and rules for working in a clean room. This includes following the gowning procedure, covering hair in a hairnet, and wearing personal protective equipment as appropriate.
• While performing the duties of this Job, the employee may occasionally be exposed to moving mechanical parts when in testing or production areas.