Technical Writer

Title:

Technical Writer

Location:

5050 Nathan Lane N. Plymouth MN USA 55442

Duration:

12 Months

100% Onsite

Responsibilities

Creates and modifies labeling for product labels, cartons and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines, and branding guidelines.

Supports a cross‑functional team collecting labeling content and translating it into functional label layouts utilizing labeling software. Mostly works on commercialized product labels.

Works with other functions to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives.

Creates and manages labeling change requests within the document management system.

Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing, and production techniques.

Schedule/deadline provided for assigned work/tasks.

Maintains knowledge of new developments in packaging and labeling technologies.

Manages multiple concurrent deadlines.

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Education Level

Bachelor’s Degree in any field. (± 16 years)

Experience/Background

Minimum 1 year in a similar capacity and/or medical device.

Experience Details

Working with product labeling, design dossiers, quality systems, and/or regulatory labeling.

Required experience developing artwork and graphics for FDA regulated medical products and creation and management of change requests in an electronic environment.

Experience utilizing computer‑aided design equipment and/or graphic tools such as CAD, Adobe Illustrator/Photoshop, and other related software.

Ability to schedule and organize multiple projects.

Ability to communicate effectively with internal and external customers and team members.

Thorough knowledge of FDA, GMP, and ISO guidelines.

Requires ability to be innovative, resourceful, and work with minimal direction.

Requires excellent organization, problem‑solving, and communication skills and the ability to work effectively with cross‑functional teams.

Experience working in a broader enterprise/cross‑division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

Ability to work within a team and as an individual contributor in a fast‑paced, changing environment.

Ability to leverage and/or engage others to accomplish projects.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes, and meets deadlines in a timely manner. Strong organizational and follow‑up skills, as well as attention to detail.

Benefits

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account (for High‑Deductible Health Plans)

Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)

Supplemental Life Insurance

Short Term Disability (coverage varies by state)

Long Term Disability

Critical Illness, Hospital coverage, Accident Insurance

MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance

401(k)

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