Technical Writer - Engineering Support - Medical Device
Reading Metro Area, PA
Experience in GMP environment as it relates to medical device manufacturing and with writing, executing and routing charters, feasibility studies, validation protocols, risk assessments and other project documents and specifications.
Candidate must to have current experience using recent versions of Microsoft Word, Excel and Visio programs.
- Technical writer with experience working with and executing technical and project documents associated with projects including, but not limited to: cost improvement, product and process improvement (material & supply changes), equipment and product validation and verification activities, etc.
Duties include the following activities under the guidance of a project manager and/or engineering manager:
- Create and revise various types of technical documents
- Work with Manufacturing Engineers, Supervisors and production staff to create/revise process work instructions
- Create and distribute meeting minutes to document issues, resolutions and action items; follow-up on action items with responsible person(s)
- Work with the Manufacturing Engineers as needed to prepare/complete documents, specifications and reports; may support completion of documents/tasks for pending projects
- Track document review and approval routings; accurately track status of multiple documents
- Work with Manufacturing Engineer(s) relative to dimensional and mechanical features as needed for protocols, reports, specifications, work instructions, etc.
- Communicate with internal employees and external suppliers as needed
- Required Skills:
- 3-5 years in a position demonstrating development, coordination and control of technical documentation activities per standards associated with a strictly regulated manufacturing environment
- Proficiency in Microsoft Office Suite
- Excellent interpersonal and written communication skills
- Excellent organizational and time management skills
- Ability to work independently and within a team as needed
- Flexibility to work in an office and production environment (may include clean room environment)
- Additional Skills Preferred:
- 5+ years in a GMP medical device environment
- Statistical analysis experience with software
- Experience with 2D drawing and/or 3D modeling software
- Experience working in a clean room environment
- Demonstrated ability to work on multiple projects