Technical Writer - Medical Devices

Technical Writer

Job Title

Technical Writer

Job Description

You have the opportunity to:

Be a part of Philips Sleep & Respiratory Care (S&RC) Research & Development (R&D) global hardware engineering group as a Technical Writer focused on technical contents including labels for medical devices. Be part of organization with culture of Impact with Care for patients, people, and planet with patient safety, quality and integrity at the heart

You are responsible for:

• Works under minimal supervision and review for technical writing duties, processes, and roles outlined below and serves often as a labeling project manager for the products assigned
• Member of project team for assigned products and provides labeling analysis on the Product Development Plan.
• Supports labeling activities for sustaining projects, and labeling updates needed due to changes in US or international regulations.
• Creation, revision, and execution of Labeling Plans for assigned products in the US and international markets.
• Creation, revision, review, and approval of Labeling (User Manuals, Provider Manuals, Quick Start Guides, Product Labels, Packaging Labels, Help Files, etc.)
• Partners with Translation Coordinator(s) throughout the execution of the associated Labeling Plans.
• Interfaces with Business Unit functions as needed to resolve labeling concerns and supports labeling process improvement efforts as needed.
• Develops and maintains proficiency in US and international regulations and standards, with a focus on Labeling for assigned products and global impact but a regional focus on the US (FDA), EU (MDD), Canada (Health Canada), Brazil, China, Japan, and Australia.

To succeed in this role, you should have the following skills and experience:

• Experience with page layout, word processing, computer-generated illustrating, and document control with Tools: Adobe Acrobat, Adobe In-Design, Adobe Illustrator, SnagIt, RoboHelp, Microsoft Office, SAP
• Bachelor’s or master’s degree in Electronics, Software, Mechanical, Biomedical Engineering
• More than 3 years of experience in technical documentation for medical device industry
• Practical experience of medical device content management system
• Hands-on experience for development and sustenance of medical device and parts labels
• Expertise in design documentation including requirements specification, label artworks, test plans, test procedures, test records
• Well versed with New Product Introduction (stage gate process) & Life Cycle Sustenance of medical product
• Hands-on experience in medical device documentation: DHF, DMR, BOM and Spec release
• Exposure to International Quality and Regulatory Standards e.g. IEC, FDA, CFR, MDD, UL, CE, CSA, BIS
• Fluent in verbal and written English, proactive, can-do attitude, team player, decisive and entrepreneurial attitude, strong analytical and problem-solving skills
• Display perseverance & agility with execution excellence mindset

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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