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Business Analyst Medical Devices

Hybrid in Minneapolis, MN, US • Posted 21 hours ago • Updated 21 hours ago

Contract W2

Contract Independent

Hybrid

$60 - $70/hr

Fitment

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Job Details

Skills

Business Analyst
Medical Devices
FDA
ISO 13485
HIPAA Life Sciences
Biomedica

Summary

Job Title: Business Analyst Medical Devices

Location: Minneapolis, MN Hybrid

Duration: 6+ Months

Job Description

We are seeking a detail-oriented Business Analyst with experience in the medical devices domain to bridge business needs and technical solutions. The ideal candidate will work closely with stakeholders, regulatory teams, and development teams to deliver compliant and high-quality solutions aligned with healthcare standards.

Key Responsibilities

Gather, analyze, and document business and functional requirements from stakeholders
Work closely with product owners, QA, and development teams to translate requirements into technical specifications
Ensure compliance with healthcare and regulatory standards such as FDA, ISO 13485, and HIPAA
Conduct gap analysis, impact analysis, and risk assessments
Support product lifecycle activities including design, development, validation, and post-market surveillance
Create user stories, BRDs, FRDs, and use case documentation
Participate in UAT (User Acceptance Testing) and validation processes
Collaborate with cross-functional teams including regulatory affairs, clinical, and quality teams
Assist in data analysis and reporting for product performance and improvements

Required Skills & Qualifications

Bachelor s degree in Business, Life Sciences, Biomedical Engineering, or related field
5+ years of experience as a Business Analyst, preferably in the medical devices or healthcare domain
Strong knowledge of medical device regulations and standards (FDA, ISO 13485, IEC 62304)
Experience with Agile/Scrum or Waterfall methodologies
Proficiency in tools like JIRA, Confluence, MS Visio, Excel
Strong analytical, communication, and documentation skills
Experience in requirements traceability and validation

With Regards,

Dinesh B

CS Solutions, Inc

7525 Mitchell Road, Suite 106, Eden Prairie, MN 55344

Email ID -

Direct Number

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: CSSOL
Position Id: 8960932
Posted 21 hours ago

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