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Sr Business Analyst - PLM
Mounds View, Minnesota  |  Remote
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Applied on June 21, 2021
Job Id #47729 Posted May 18, 2021


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This Sr IT Principal Analyst role carries with it the opportunity to be a part of the Requirements and Risk Management Workstream for the Product DNA program.

Product DNA is an ecosystem that creates a connected thread of product information, harnessing the collective ingenuity of employees across functions, enabling better collaboration with customers and partners, to rapidly deliver quality products and services, ultimately improving more patients lives.

A DAY IN THE LIFE

  • Work with the workstream lead to gather business requirements with User Stories.
  • Document business requirements & functional designs.
  • Establish backlog of user stories and specify the WHO, WHAT, WHY as well as Acceptance Criteria.
  • Interact and work closely with the business users to understand their technical and business needs.
  • Ensure applicable compliance and regulatory requirements are recorded.
  • Oversee testing and defect management process for User Acceptance Testing (UAT).
  • Participate in Daily Scrum meetings and interface with workstream lead as required for clarifications.
  • Coordinate demos, conference room pilots and testing.
  • Support training content creation.
  • Test functionality of systems to ensure it meets the business users needs.
  • Review integration, system, and UAT scripts.* Work w/ testers in the Release Team to validate scripts.
  • Help build the institutional solution knowledge for long-term business understanding & support.
  • Work w/ Global Process Lead to update QMS document per process changes.
  • Work w/Validation Lead to author/update applicable validation documents .

MUST HAVE (Minimum Qualifications)

  • Bachelors degree with 10+ years of experience with or 8+ years of experience with an advanced degree
  • Relevant experience including:
  • Broad multi-functional business and PLM experience
  • Systems Engineering and Application Lifecycle Management (ALM).
  • Drive for continuous improvement and a passion to be a change agent.
  • Proven record of impactful contribution to enterprise-wide projects.
  • Must be comfortable with ambiguity, adept at change management, and capable of working in cross functional teams.
  • Excellent facilitation and issue resolution skills.
  • Self-motivated individual with passion to succeed.
  • Experience working in an FDA/ISO regulated environment.
  • Experience with other Product data platforms like: PLM, ERP, PIM, etc.
  • Solid experience in requirement and risk management aspects throughout the product lifecycle, related to functional specs to ensure that a product, service, or system meets, and fulfills its intended purpose, including:
  • The management of requirements by identifying, analyzing, decomposing, allocating and resulting traceability to system components
  • Communicating and maintaining configuration control of the set of requirements
  • Risk management through systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling, and monitoring risk. Encompasses hazard analysis, risk analysis and risk control measures
  • VOX informed design for systematically gathering and interpreting feedback from customers, regulatory sources, competitors and other stakeholders on the use of a product to guide the development of new, related products or improvements on an existing product.
  • Experience with requirement gathering and testing in a design control environment.
  • Experience with master data management.
  • Experience driving work across a global, matrixed organization.

NICE TO HAVE (Preferred Qualifications)

  • Preference given to current employees
  • Priority consideration will be given to local applicants
  • Strong knowledge and understanding of EU MDR requirements.
  • Financial acumen
  • Knowledge of Quality Management Systems and Regulatory requirements for compliance.

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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EQUAL OPPORTUNITY EMPLOYMENT SURVEY

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You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

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