Systems Engineer - Exp in assay development at a medical device company

Overview

On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

Systems Engineer with experience in assay development at a medical device company

Job Details

Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting services as well as prepackaged, industry specific solutions and services to companies around the world. Our Consulting Services are dedicated to helping our clients maximize their investments in IT and the overall effectiveness and efficiency of the business. Tranzeal s deep industry experience makes us the partner of choice for a growing number of Fortune 1000 companies, midsize enterprises and small businesses worldwide.

We are currently looking for 'Systems Engineer - Experience in assay development at a medical device company' to support one of our clients with the following skills:

Requirement:

Job Title: Systems Engineer - Assay Development

(Experience in assay development at a medical device company)
Location: Tucson, AZ
Duration: 12+ months

Required Skills:
Proven experience in systems engineering focused on requirements engineering, risk management, and verification & validation in medical device or assay development.
Strong knowledge of regulatory standards (FDA, ISO) relevant to diagnostics, with expertise in traceability, risk, and validation.
Familiarity with assay development processes, including cytology assays and clinical workflow applications.
Skilled in requirements elicitation, risk analysis methodologies (like FMEA), usability engineering, and V&V test strategy formulation.
Excellent cross-functional collaboration and communication abilities, with leadership experience in facilitating complex technical discussions.
Good to have proficient in using technical tools such as RETINA for requirements and test integration, and LucidSpark/LucidChart for visual collaboration.
Advanced understanding of software engineering, electronics, electro-mechanical systems, IT, and basic chemistry to support comprehensive system requirements and validation.

The national base pay range below is a good-faith estimate of what our client may pay for new hires. Actual pay may vary based on Client's assessment of the candidates knowledge, skills, abilities (KSAs), related experience, education, certifications and ability to meet required minimum job qualifications. Other factors impacting pay include prevailing wages in the work location and internal equity. $37 - $39 per hour on W2.

Note: Please send your updated resumes to sureshs(at)tranzeal(dot)(com)

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