Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Stryker Neurovascular focuses on saving lives: Treating and preventing strokes is our focus. From the moment a product is manufactured to its use in the angio-suite, the Associate Manager, Technical Publications makes a difference in so many ways.
The Associate Manager, Technical Publications contributes to new product development and design change (sustaining) activities in the areas of label design/release, technical writing, development of artwork/images and development or improvement of processes for improved efficiency and compliance.
This role will engage with and mobilize cross functional teams to resolve obstacles effectively, be responsible for meeting key labeling objectives, and lead continuous improvement initiatives or special activities having business impact.
Who We Want: Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
Service-oriented and Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success while focusing on its customers, their requirements, and needs.
Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to be ready for what's next.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
What You Need:
6+ years of relevant technical experience
Bachelor's degree in Graphics or Language or equivalent experience (Advanced degree may be considered towards years of experience)
2+ years of people management experience in FDA regulated Medical Device industry or similar
Required to have a high level of service and responsibility in managing a high and varied workload from internal customers and be comfortable working to tight timelines
Provide weekly summary of activities, create project plans, prioritize, and effectively communicate updates to customers
Follow Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training for incumbent position
Qualifications/Work Experience Required:
Demonstrated extensive application using database driven labeling system such as Prisym ID, Label View, Loftware, Bartender Nice Label, and Easy Label.
Extensive knowledge of:
Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator)
Microsoft applications (Word, Excel, PowerPoint, and Visio)
Demonstrated competency of 21 CFR 820, ISO13485, ISO 14971, and other international standards
Ability to manage multiple projects simultaneously and prioritize work, goals, and tasks for the team
Strong attention to detail and exceptional problem-solving skills
Experience with PLM and document control systems, (Windchill specific experience a plus)
Ability to lead, motivate, coach, and develop a strong team
Exercises good judgement and promotes a Quality Culture within the R&D function as well as the company
What You Will Do:
Directly manage team of Technical Publications Specialists to develop Instructions for Use, User Guides and required labeling for all Stryker Neurovascular products. This includes working with project teams for new product development, post-market design changes and international launches.
Additional duties include but not limited to the following:
Keeps track of med device and technology trends within the technical publications space and uses it to lead research about products, service, technology, trends in usability testing, and test method and documents in a clear, most logical way for reader comprehension
Lead investigations, root cause analysis (RCA) related to continuous improvements (NCs/CAPAs), quality plan development and execution, assessment of current procedures, and identification of best practices.
Leads benchmarking quality against Corporate and industry leaders
Front Room Technical Lead to manage record gathering in defense of design choices in support of internal and external audits with technical content
Works with high latitude for unreviewed action or decision to support recertification and other compliance projects in addition to influencing major design directions and decisions
Fully support the Quality Policy by building quality into all aspects by maintaining compliance to all quality requirements and leading improvements that make it easier for the organization to maintain compliance in highly complex areas
Subject Matter Expert (SME) in all technical publications areas with demonstrated extensive application of knowledge through delivery of quality deliverables (SOPs, technical literature and Work Instructions; engineering work product) to ensure continuity of content style that meets applicable standards and appropriate for its intended audience
Lead set up of labeling system, collaborate with IS team, train and implement associated templates for newly acquired franchises
Power user of PrisymID labeling system or other database driven labeling system. Trains new technical publications staff and may serve as consultant resource for other Stryker divisions
With knowledge of internal and external customer requirements, designs and develops the look and feel of product labeling (colors, formats, layout, etc.) and documents within procedure appropriately.
Follows industry trends and benchmarks against other Corporate entities and other companies.
Leads other technical publications staff in refining existing and developing more efficient label verification and implementation process
Leads research, development, documentation and execution of technical specifications, scripts and troubleshooting for very complex electronic issues related to IFU and other compatible systems
Monitors and trends software defect and propose solutions appropriate for compliance and customer satisfaction.
Serves as Subject Matter Expert on Corporate Hub and Spoke for eIFU and other e-labeling.
Leads IFU development and release in PLM for new product development and design changes in conjunction with product labeling to ensure congruency with exceptional attention to detail
Apply detailed knowledge of ambiguously defined customer issues and associated task to lead IFU/Literature printing suppliers
Proposes designs that are compliant for targeted regions and have a high degree of usability by Health Care Professionals (HCPs) and patients.
For Global products, drive harmonization in design and content.
May be required to act as a player coach within the technical publications area.
Performs other duties as assigned by manager.
Assists with the planning and implementation of new programs, services, and projects; monitors progress and evaluates results; recommends changes or other action as appropriate.
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK