Pr. Technical Writer, Labeling

ABOUT INSPIRE MEDICAL SYSTEMS 

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients' lives through sleep innovation.  We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

WHY JOIN OUR FAST-GROWING TEAM 

At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. 

If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team 

ESSENTIAL JOB FUNCTIONS  

This position designs, develops and updates product shelf box and sterile tray labels, product manuals, quick reference guides, and other customer-facing technical documentation for existing medical device products. As a subject matter expert (SME), this position will collaborate with other team members across the organization including Manufacturing, Quality, Development, Marketing, Clinical Research, Regulatory Affairs, and contract manufacturers to define and maintain product labeling requirements while ensuring the labeling is accurate, visually appealing, cost-efficient, manufacturable, and compliant with applicable regulations, industry standards, and company requirements.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE  

• Work with product stakeholders to develop and implement geography specific and global labeling strategies for existing products.
• Work with internal and external stakeholders to define and manage labeling deliverables for existing products including product manuals, quick reference guides, shelf box labels, sterile tray labels, and other customer-facing technical documentation.
• Attend project meetings and communicate with stakeholders as necessary to define and maintain product labeling requirements.
• Evaluate, troubleshoot, and maintain existing templates, and design new templates where needed.
• Develop text, simple graphics, and update illustrations for labeling deliverables.
• Develop and manage the tools needed (e.g., terminology sheets and style manuals) that ensure consistency across UI terminology and labeling deliverables.
• Coordinate with contract manufacturers on creating and updating label printing files and ensure labeling requirements can be met.
• Create and manage change requests for labeling change approval and release.
• Communicate labeling deliverable timelines to cross-functional team and project manager.
• Prepare deliverables for printed, e-labeling, or on-line help delivery.
• Coordinate with translation vendor.
• Perform first article inspections on labeling.
• Manage multiple projects concurrently, while complying with good manufacturing practices, quality systems standards, and FDA and global labeling regulatory requirements.
• Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.
• Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations as required for this position within the required timeline.
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required: 

• 5+ years of labeling experience and/or technical writing experience from a regulated medical manufacturing industry (i.e. medical device or pharmaceutical, etc.)
• Demonstrated experience managing multiple projects simultaneously
• Proficiency with Adobe FrameMaker, In-Design and Creative Suite
• Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership
• Proficient with MS Suite (Word, Excel, Outlook)
• Bachelor's Degree in Technical Communication or a related discipline

Preferred:

• 8+ years of labeling experience and/or technical writing experience in medical device manufacturing
• Proficiency with other label software packages such as Bartender, NetSuite, Loftware, Label View or Label Live

#LI-Onsite

The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.   

BENEFITS AND OTHER COMPENSATION

Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis. 
 
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at or email (dot)com  
 
Inspire Medical Systems participates in E-Verify.