Engineering Documentation Specialist

LifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. 

JOB SUMMARY:

The Engineering Documentation Specialist is responsible for taking complex technical information and translating it into an easily understandable format, according to internal document guidelines. In this role, you will work closely with the Product Development and Manufacturing Engineering staff and other internal employees to create or revise product design and manufacturing process engineering documentation, CAD drawings, and other documentation as required to meet internal and regulatory requirements. The Engineering Documentation Specialist will also drive the review, finalizing and routing of engineering documents for approval.

DUTIES & RESPONSIBILITIES:

• At the direction of the engineering staff, write new and revise existing technical documents including requirements documents, product design and manufacturing process specifications, verification and validation protocols and reports, and other supporting technical documentation.
• Drafts text materials to ensure text and illustrations are completed and coordinated per product or process requirements.
• Review, circulate, edit, assemble, and route engineering documentation for approval through FileHold and AEGIS FactoryLogix electronic management systems for approval routing of technical documentation.
• Communicates status of work and any requirements for additional information to engineering staff and management.
  Completes assigned tasks in a timely manner and to meet project deadlines
• Performs any other job-related instructions, as requested, with reasonable accommodation.

WORK EXPERIENCE:

• Demonstrated experience writing, editing, and managing engineering and technical documentation used in the development and manufacturing of new products and improvement of existing products.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with electronic document management systems and engineering documentation.
• Working knowledge and prior exposure to AutoCAD and SolidWorks
• Excellent communication and interpersonal skills.
• Experience with experimental design and data interpretation is preferred.
• Ability to work independently and manage multiple priorities
• Demonstrated ability to work collaboratively with cross-functional teams.

EDUCATION AND/OR TRAINING:

• Associate’s or Bachelor’s in Engineering Technology, Science, or equivalent technical degree or combination of education and work experience
• Minimum 3 years relevant experience in a related area such as R&D, Technical Product Development, or Quality in a medical device or other regulated industry.
• Good working knowledge of personal computer software programs in Windows environment.  Experience with document management software applications is preferred.
• Society of Technical Writers certification a plus.

WORK HOURS:

• Non-Exempt Position; Shift 8 a.m. to 4:30pm M-F
• Minimum of 40-45 Hours Week, or other agreed upon documented schedule

BENEFITS:

• Health, Dental & Vision Insurance
• 401(k)
• Paid Time Off
• Flextime/ work-from home