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Engineering - Technical Writer - Exempt

Lancesoft

Minneapolis, MN

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JOB DETAILS
SALARY
$50
SKILLS
Communication Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, Documentation Review, Editing, FDA (Food and Drug Administration), Maintain Compliance, Medical Equipment, Medical Terminology, Multitasking, Organizational Skills, Problem Solving Skills, Product Development, Product Documentation, Product Lifecycle Management, Project/Program Management, Prototyping, Quality System Requirements (QSR), Regulations, Support Documentation, Team Player, Technical Writing, Time Management
LOCATION
Minneapolis, MN
POSTED
30+ days ago

Join our team in Minneapolis, MN, where you'll be part of a dynamic environment that supports the creation of innovative medical device solutions. As a Technical Writer, you'll be integral to developing high-quality documentation that supports our Neuromodulation and Pelvic Health portfolios.
Must Have
  • Quality/Compliance Mindset
  • Technical Writing/Documentation
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
  • 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.
  • Manage multiple projects and priorities while meeting expected timelines.
  • 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.
Requirements
Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience. The ideal candidate will have a practical knowledge and demonstrated competence within the job area.

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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