Documentation Specialist
About the Company
Integer Holdings Corporation (ITGR) is one of the largest medical device outsource (MDO) manufacturers in the world, serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical, and portable medical markets. The company provides innovative, high-quality medical technologies that enhance the lives of patients worldwide. Additionally, it develops batteries for high-end niche applications in energy, military, and environmental markets. Brands include Greatbatch Medical, Lake Region Medical, and Electrochem.
About the Role
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values—Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity—are embedded in everything we do. This role adheres to Integer’s Values and all safety, environmental, security, and quality requirements, including Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies, and operating procedures.
Responsibilities
- Research, plan, edit, write, and coordinate the development and edits of technical documents used internally.
- Work closely with engineers and production team members to understand documentation needs and implement changes following all internal and external requirements.
- Ensure documentation is consistent, clear, technically accurate, complete, and meets regulatory, marketing, and branding requirements.
- Commit to scheduled completion dates and inform management if adjustments are needed.
- Support project teams by developing, communicating, and maintaining project estimates, schedules, and status.
- Organize and facilitate content and quality reviews of manufacturing procedures, qualification and validation documents, prints, specifications, etc.
- Manage the change release of production documentation using PDM (Reliance).
- Assist in the maintenance of internal systems and procedures to ensure consistency of format, style, clarity, safety, and technical accuracy.
- Perform other duties as assigned.
Requirements
- Bachelor’s degree in Technical Writing, English, Communications, or a technical field with coursework in technical writing.
- 1-3 years of experience in technical writing or related experience in the medical device industry.
Skills
- Demonstrated ability to write clearly and concisely.
- Ability to manage multiple projects, sometimes with short or changing deadlines.
- Excellent people and communication skills.
- Strong organizational skills and attention to detail.
- Proficiency in MS Word, PowerPoint, and Acrobat.
- Knowledge of medical device regulations as they relate to documentation requirements.
- Experience with engineering projects and working within an international organization.
Pay
Salary Range: $58,575.00–$85,910.00
Benefits
- Comprehensive benefits package with immediate eligibility, including medical, dental, vision, disability, life insurance, and adoption benefits.
- Parental leave available after one year.
- Optional employee-paid programs: supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
- Immediate eligibility to participate in the 401(k) plan with company matching contributions.
- 80 hours (10 days) of company-designated holidays per year plus an annual allotment of paid time off.