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Engineering - Technical Writer - Exempt

Lancesoft

North Haven, CT

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JOB DETAILS
SALARY
$45
SKILLS
Adobe FrameMaker, Adobe InDesign, Communication Skills, Cost Estimates, Cross-Functional, Data Collection, Delivery Management, Documentation, Engineering Change Management, Engineering Change Order, Illustrating Ability, Interviewing Skills, Medical Equipment, Medical Writing, Presentation/Verbal Skills, Product Requirements Document (PRD), Product/Service Launch, Quality Management, Regulations, Regulatory Submissions, Technical Writing, Writing Skills, XML Tools
LOCATION
North Haven, CT
POSTED
14 days ago

Join our team and contribute to the development of cutting-edge medical device labeling. This role is based in North Haven, CT, a vibrant location offering a balance of onsite collaboration and remote work flexibility.
Key Responsibilities
  • Plan, research, develop, and write medical device labeling, managing deliverables as part of cross-functional project teams under general supervision.
  • Simultaneously manage up to two labeling updates and one small, new-product-introduction project involving multiple labeling pieces.
  • Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
  • Conduct interviews with various users and technical staff to gather data for documentation.
  • Recommend formats responsive to technical and customer requirements.
  • Assist in providing documentation for CAPAs, and departmental and business-unit audits.
  • Contribute to time and cost estimates for labeling deliverables for project teams.
  • Develop illustrations in cooperation with professional illustrators.
  • Participate in department and business-unit initiatives.
  • Oversee the Engineering Change Order process for labeling.
  • Coordinate translations and track the status of translations.
  • Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.
Qualifications
  • Strong collaboration, verbal/written communication skills, and technical writing core competencies.
  • Experience with various authoring tools (e.G., InDesign, Framemaker, XML tools).
  • Experience in complex regulatory environments and robust quality processes.
  • Requires a University Degree and a minimum of 5 years of relevant experience, or an advanced degree with 2 years of experience.
Additional Information
This role requires being onsite 4 days a week, with 1 day remote. Candidates should be located within a reasonable commuting distance to North Haven, CT, as onsite requirements cannot be changed. We are looking to hire and start as soon as possible.

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/