The Role
Perform manual testing and computer system validation for web, mobile, and desktop applications in regulated environments. Create and execute test cases and validation plans, document URS/FS/IQ-OQ-PQ, track defects, perform impact assessments/change control, and maintain validation documentation per GxP and regulatory standards.
Summary Generated by Built In
Work Flexibility: Hybrid
Job Summary:
The Software Testing & Computer System Validation (CSV) Engineer is responsible for manual testing of software products and tools required at developmental and verification stages along with ensuring computerized systems used in regulated environments (e.g., GMP, GCP, GLP) are validated in compliance with applicable regulatory requirements such as 21 CFR Part 11, Annex 11, GAMP 5.
What you will do
- Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira).
- Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups
- Develop and execute validation strategies and plans for new and existing computerized systems.
- Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessment; Validation Plans (VP) ; IQ/OQ/PQ Protocols and Reports; Traceability Matrix.
- Perform impact assessments and change control activities for validated systems.
- Provide training and guidance on CSV processes and best practices.
- Maintain validation documentation in alignment with company procedures and regulatory expectation
What you will need:
Required:
- Experience- 1yrs to 3 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices).
- Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field.
- Good understanding of SDLC, and defect life cycle; Experience with bug-tracking/project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications.
Preferred :
- Understanding of software development life cycle (SDLC) and risk-based validation approaches; CSV certifications (e.g., ISPE, PDA) or GxP training; ISTQB Certification
- Experience in data integrity assessments and remediation projects; Familiarity with cloud-based systems and cybersecurity considerations.
- Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.
- Excellent documentation, reporting, communication, and project management skills.
Skills Required
- 1 to 3 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices).
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
- Good understanding of SDLC and defect life cycle.
- Experience with bug-tracking/project management tools (e.g., Jira, Devops).
- Experience validating systems such as Valgenesis and custom applications.
- Knowledge of GAMP 5, 21 CFR Part 11, and Annex 11.
- ISTQB, CSV certifications (ISPE, PDA) or GxP training.
- Experience in data integrity assessments, cloud-based systems, and cybersecurity considerations.
- Excellent documentation, reporting, communication, and project management skills.
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
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The Company
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
