Engineering - Technical Writer - Exempt

Lancesoft; Minneapolis (MN); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Lancesoft is seeking a Technical Writer for its Minneapolis, MN site to support the production of customer-facing product documentation for medical device labeling and instructions for use (IFUs). You will work with cross-functional teams to ensure content accuracy and regulatory compliance across multiple projects.

The role emphasizes quality, organized project management, and the ability to handle complex documentation within a regulated environment.

Qualifications

• Must-have: Quality/Compliance mindset and strong technical writing/documentation skills.

Responsibilities

• Develop labeling products and associated documentation, including prototyping, editing, formatting, and coordinating reviews and approvals.
• Collaborate with colleagues and cross-functional partners to ensure accuracy and quality of labeling content.
• Management of multiple projects and priorities while meeting expected timelines.
• Revise, edit, and format legacy product documentation such as user guides, service manuals, instructions for use (IFUs).
• Ensure labeling compliance with regulatory/QSR requirements and EU MDR where applicable.

Skills

Quality/Compliance Mindset

Technical Writing/Documentation

Job description

Join our team in Minneapolis, MN, a vibrant city known for its rich cultural scene and thriving business environment. As a Technical Writer, you'll play a crucial role in supporting the production of customer-facing product documentation, including user guides, service manuals, and instructions for use (IFUs) for medical device products.

Must Have Skills

• Quality/Compliance Mindset
• Technical Writing/Documentation

Nice to Have Skills

• Adobe Indesign
• Content Management System
• Experience working in a federally regulated environment (FDA)
• Experience with the European Union Medical Device Regulation (EUMDR)
• Familiarity with Quality/CAPA processes and principles
• Self-directed and highly organized
• Ability to manage multiple priorities
• Excellent communication skills
• Advanced writing/editing skills
• Cross-functional collaborative nature
• Product Lifecycle Management software experience
• Medical terminology experience
• Familiar with the principles of neuromodulation
• Product development workflow

Main Responsibilities

• Development of labeling products and associated documentation, including prototyping, editing, formatting, and coordinating reviews and approvals.
• Collaboration with colleagues and cross-functional partners to ensure accuracy and quality of labeling content.
• Management of multiple projects and priorities while meeting expected timelines.

Typical Responsibilities

• Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating change order release.
• Revise, edit, and format legacy product documentation as required, including user’s guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs).
• Ensure compliance of labeling with all applicable regulatory/QSR requirements.
• Create, edit, and format documentation as part of compliance with requirements from the European Union (EU Medical Device Regulation).
• Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews, and verification deliverables.
• Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
• Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.
• Continually review the document development process to ensure quality in labeling output.

Target Experience

1-8 years of experience

Work Environment

Primarily onsite (4 days minimum), with the option to work remotely 1 day per week.