Systems Engineer - Product Information (US - Pittsburgh, PA)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   

Owns definition, creation, execution, and maintenance of technical documentation and product labels for Smith+Nephew's New Product Development and other projects. This role collaborates with various functions to understand, develop, and maintain all aspects of technical documentation across projects and product families.

• Develop technical documentation strategy according to program and product needs.

• Develop (research/write/illustrate) content, including understanding and communicating detailed technical concepts.

• Work closely with R&D Engineering, Regulatory, Quality, and Marketing to create any new project-related technical documentation and to make ongoing updates that are a result of user feedback, review of risk management file, and to support regulatory and quality compliance.

What will you be doing?

• Own development of labeling (user manuals, package inserts, addendums, labels) throughout product development life cycle and maintain labeling throughout product launch and global expansion of product.

• Defines and produces technical documentation including user manuals, package inserts, and other technical guides.

• Defines and designs labels based on input from cross-functional team.

• Analyzes and updates existing and new documents to maintain continuity with regulations and project needs.

• Confers with project managers, engineers, and regulatory experts to establish technical specification, determine text and illustrations to be developed for publication, and ensure accuracy of product documentation.

• Determines technical documentation priorities based on timelines and resource capacity.

• Anticipates potential project problems and creates solutions or contingency plans.

• Manages workload and label/technical documentation interdependencies across multiple projects.

• Maintain DHF and DMR documents related to technical documentation and labels (labeling indexes, labeling requirements, labeling descriptions, labels).

What will you need to be successful?

• Bachelor's Degree in Engineering, English, Technical Writing, Communications, or related work experience

• 5+ years technical writing experience

• 2+ years in regulated industry preferred: High-tech, medical device labeling and documentation development experience preferred

• Proficiency in Microsoft Office required and Adobe Creative Suite (InDesign, Acrobat Pro and Illustrator) preferred

• Self-starter

• Detail oriented

• Critical and strategic thinking

• Results driven individual

• Excellent written and spoken communication

• Able to work cross-functionally with project team members

• Able to multi-task across many concurrent projects

• Willingness to work outside of typical job duties to support the team

• Able to effectively lead small to medium sized teams

• Familiarity with translation process, global product launch requirements, and eIFU

• Standards familiarity: ISO 13485, ISO 14971, ISO 15223, IEC 60601-1

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ( https://www.smith-nephew.com/).

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  

• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program 

• Flexibility: Hybrid Work Model (For most professional roles)  

• Training: Hands-On, Team-Customized, Mentorship  

• Extra Perks: Discounts on fitness clubs, travel and more!  

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.