Inspire Medical Systems · 1 day ago
Pr. Technical Writer, Labeling
Minneapolis, MN
Full-time
Onsite
Senior Level
$110K/yr - $150K/yr
5+ years expInspire Medical Systems is a pioneering company focused on improving the lives of individuals with Obstructive Sleep Apnea through innovative medical devices. The role of Principal Technical Writer involves designing and developing technical documentation for medical device products, collaborating with various stakeholders to ensure compliance and accuracy in product labeling.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
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
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
Qualification
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
Benefits
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.
Company
Inspire Medical Systems
Inspire Medical Systems develops implantable therapeutic devices for the treatment of obstructive sleep apnea.
1001-5000 employees
H1B Sponsorship
Inspire Medical Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (2)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$319.4MKey Investors
Amzak Capital ManagementOrbiMedMedtronic
2020-04-13Post Ipo Equity· $133.4M
2018-12-18Post Ipo Equity· $75M
2018-05-03IPO
Leadership Team
Tim Herbert
Chairman & CEO
Richard Buchholz
CFO
Recent News
2026-01-07
Company data provided by crunchbase