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
23 month contract
As a member of the Technical Publications team, support R&D Business Units, Product Engineering and Regulatory Affairs to meet labeling requirements for global product compliance and distribution. Fully remote working is possible.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.
KEY AREAS OFRESPONSIBILITY
Develop and support multiple simultaneous projects for product labels
Support multiple simultaneous translation projects Instructions For Use (IFUs).
Advise on translation strategies that satisfy international labeling needs for Business Units including Mergers & Acquisitions, compliance elements related to localization, and related distribution strategies.
Inform Business Units on relevant aspects of the labeling process such as requirements, costs, and timelines.
Determine level of risk for "at-risk" investment of pre-approved English text and communicate impact of language translation for packaging and/or distribution and project timelines.
Ensure labels including translations are executed in an efficient and timely manner through collaboration with an external translation service.
Review labels and IFUs for completeness and presentation.
Utilize a variety of specialized software to support labels and IFUs: desktop publishing, specialized label software, translation management software, PLM/CMS system for labeling releases/updates. Perform troubleshooting of electronic files as needed.
As needed, engage in support activities related to publication of IFUs to eIFU website
Communicate to finance department on purchase orders and invoicing related to translation as required.
Initiate/assist with departmental continuous improvement endeavors.
Track data/metrics associated with functional area.
May assist with internal and external regulatory audits.
May provide reviews of regulatory documents to ensure medical device labeling references are correct.
QUALIFICATIONS KNOWLEDGE SKILLS
Bachelors Degree in an Engineering discipline.
Bachelors Degree in an Engineering discipline or equivalent
2+ years experience of leading product development projects and managing new product commercialisat ion in a high performance engineering industry (e.g. medical device, automotive, aerospace etc.).
Experience in a regulated environment preferred
Individual will be expected to help drive change through influence.
Strong communication skills across a diverse audience and an ability to integrate well with AO, PD, Ops, Marketing, finance etc.
Demonstrated use of best practice methodologies such as six sigma, SPC, capability analysis, R&R, DOE, DFM, GD&T
Experience of statistical methods and design, product and process validations would prove beneficial.
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