Full-Time
Validation Scientist
Integrated Resources
501-1,000 employees
No salary listed
Rochester, NY, USA
In Person
 Biology & Biotech (1) |
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- BS in Clinical Chemistry, Biochemistry Biotechnology, Medical Technology, Biology or Chemistry
- Exhibits core competencies 0-4 years’ experience in one of the following fields or related fields: clinical chemistry, biochemistry, biotechnology, medical technology, biology, chemistry
- Experience or knowledge of FDA 510k’s and the design control process (Verification and Validation) for Medical Devices
- Experience or knowledge of evaluation and statistical analysis using methods such as the CLSI documents
- Experience in identifying and resolving problems for Medical Device instrumentation is a plus
- Experience working in a laboratory running and troubleshooting instruments
- Experience evaluation studies with Medical Devices
- Experience working 510k’s on Medical Devices
- Experience setting up Medical Device evaluations internally or externally with customers
- Experience with setting up Medical Device evaluations
- Running and analyzing compliant Medical Device evaluation tests on new clinical chemistry, immunochemistry, immunohematology and blood donor instrumentation during integration, verification, validation and customer validation
- Understanding how to run the analyzers as experts and understand when an analyzer runs correctly or does not
- Troubleshooting skills are required
- Clear and concise communication is key due to interacting with others in the lab and with the Evaluation Scientist
- Testing accuracy (attention to detail) is of the highest need
- Understanding the test designs and analysis is also required
- System testing involves integrating assay clinical chemistry, immunochemistry and blood donor screening in a team setting where one is responsible for effectively interacting with people representing a broad array of technical specialties to achieve success
- All work will be compliant with regulatory requirements, GCP and OCD procedures
- The candidate will be responsible for thinking broadly and unconventionally, being open to new ideas from others, experience in good verbal and written communication, effective in multi-tasking and flexibility and will be required to deliver products on time
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.