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IT Business Analyst - Medical Device Labeling (Hybrid)

Techlink Systems Inc.
Saint Paul, MN
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Job Title: IT Business Analyst - Medical Device Labeling
Location: St. Paul, MN OR Santa Clara, CA (3 days on-site, 2 days remote)
Contract Duration: 6-month contract
Work Hours: Monday to Friday, 9AM - 5PM

Job Description:

We are looking for a IT Business Analyst to serve as primary liaison between the IT and Medical Device Labeling group. The role will work directly with the label design team g team, quality groups and distribution teams and apply IT and business knowledge and experience to develop the business requirements and business case to associated to developing a labeling strategy. This role is instrumental in facilitating business involvement, decision making, and coordination of business resources to deliver and implement high quality projects and prepare business area for changes impacting their areas.

Core Responsibilities:

  • Investigate, record, analyze and confirm medical device labeling system requirements and business processes for label design and label printing.
  • Identify overlapping requirements/processes across the various existing software portfolio. Independently conceives and develops general approaches to develop business requirements and business case.
  • Produce high quality and concise requirements and design documents which accurately reflect the medical device labeling business requirements and can be clearly understood by internal or external Solution Developers.
  • Act as a key interface between the business and delivery team to ensure that business needs are clearly understood, communication between the parties is effective and user expectations are managed. Approach technical concepts in plain English and with an approachable style.
  • Research and evaluate solution options for updates to medical device labeling solutions and assist with high-level design of business and software requirements and planning of UAT, to contribute to the development of concept and business case documents for projects and enhancements.
  • Assist with training and documentation with new system implementations / upgrades
  • Support Roadmap development for IT systems and upgrades
  • Manage a variety of tasks concurrently and show flexibility of work patterns to meet time-frames and delivery.
  • Work is reviewed for soundness of business judgment and to determine if overall results and objectives have been achieved.
  • Review enhancement / project submissions and prioritization scoring to ensure that all change requests have been correctly specified, justified and prioritized, in line with PMO procedures. Where required, liaise with sponsors to clarify information and assisting to resolve possible scheduling/funding issues.
  • Assess the impact of change on existing systems and processes and manage their impact in conjunction with service management teams to ensure change happens in a controlled way, with minimal disruption to business activities.
  • Communicates effectively with management to enhance their understanding of the opportunities and limitations of information systems
  • 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.

Minimum Qualification:

  • Bachelor's degree in computer science, business administration or another discipline relevant for healthcare industry
  • 10-12 years of IT experience: 5+ years of technical experience, 5+ years of experience translating business requirements into technical designs
  • Must have experience in pharmaceutical or medical device industry
  • Must have experience gathering business requirements and process mapping
  • Must have experience with Medical Device Labeling processes and systems. Experience with one of these platforms is required: EnLabel, Prisym ID, NiceLabel, Loftware or similar platform
  • Must have experience in Supply Chain, Manufacturing and Quality processes in the Healthcare industry
  • Strong customer facing skills, with the ability to translate complicated technical needs for various non-technical audiences
  • Ability to multitask in the role with little supervision and many demands from many constituents
  • Ability to drive requirements and project work through to closure
  • Strong analytical, written and verbal communication skills
  • Excellent ability to influence internal and external stakeholders and build consensus, understanding the different priorities in various teams / departments.

Techlink Systems Inc.


Saint Paul, MN
55117 USA



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