Engineering - Technical Writer

Job Title: Engineering - Technical Writer
Job ID: 28707
Location: 7000 Central Ave NE Minneapolis Minnesota 55432
Duration: 10 Months
Pay Rate: $45.00-50.00/hr. on W2

JOB DESCRIPTION
Additional position details from the manager below:
Can you please confirm your top 3 skills sets required?
Technical writing
Collaboration
Compliance with quality management system procedures

Can you please confirm the 3 main responsibilities/day to day activities required for this role?
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
What products (if any) will this role support? This role will support labeling products (user guides, implant manuals, instructions for use) associated with medical devices across the Neuromodulation and Pelvic Health portfolios.

What is your target years of experience? 1-8 years of experience
When do you plan to start interviewing? Oct 19, 2026
Will you be looking to hire and start ASAP or will the start date be delayed? Start date will be around Dec 7, 2026
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Primarily onsite (4 days minimum), with option to work remote 1 day per week

As a Technical Writer, you will support the production of customer facing product documentation, including but not limited to: user guides, service manuals, and instructions for use (IFUs). This includes both clinician and patient labeling that accompanies medical device products within the Client Neuroscience portfolio. You may work on R&D projects such as new product development and released products maintenance (e.g., sustaining activities and legacy document updates), as well as quality- and compliance- driven projects to ensure our labeling conforms to quality assurance standards and labeling requirements from external standards and regulations (e.g., FDA, EU MDR, ISO, etc.). You will be responsible for both the content in the labeling as well as the supporting documentation, which may include design plans, design input requirements and tracing documents, review documentation, and verification reports. You may also be responsible for investigation, documentation, and resolution of labeling-related quality issues.

Typical responsibilities may include:
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 but not limited to 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 the 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.

Nice to Have:
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

Responsibilities may include the following and other duties may be assigned. Creates, develops, plans, writes and edits operational, instructional, maintenance or test procedures for paper, multimedia, webbased publications and user sites; may produce content for embedded user assistance technology. Conducts interviews with various users and technical staff to gather data for documentation. Researches and translates technical information into manuals and/or web based documents for nontechnical and technical users. May document engineering processes and specifications. Recommends formats responsive to technical and customer requirements. Produces products that conform to the company documentation and quality assurance standards. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.