Systems Engineer - Assay Development - 29160_S jobs in United States
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BEPC Inc. - Business Excellence Professional Consulting · 10 hours ago

Systems Engineer - Assay Development - 29160_S

BEPC Inc is seeking a highly skilled Systems Engineer specializing in Assay Development to join their innovative R&D team. This role involves driving key systems engineering activities including requirements definition, risk management, and verification & validation practices to support advanced assay technologies and laboratory automation processes.

BiotechnologyConsulting
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Diversity & Inclusion
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H1B Sponsor Likelynote

Responsibilities

Define and manage system and subsystem requirements throughout the development lifecycle
Support system architecture development to meet IVD regulatory standards
Perform and document risk management activities including FMEA
Lead verification and validation planning and execution activities
Collaborate with cross-functional teams to ensure requirements traceability and alignment
Drive stakeholder discussions and decision-making with clear tradeoff analysis
Support configuration management practices and documentation
Design and develop comprehensive system architectures for assay development platforms, integrating hardware and software components
Collaborate with cross-functional teams to define system requirements and translate them into scalable technical solutions
Implement and manage IT infrastructure components including cloud services (AWS, Azure), virtualization (VMware, ESXi), and container orchestration (Kubernetes)
Develop and maintain APIs, RESTful services, and web services to facilitate seamless data exchange between laboratory instruments and data management systems
Conduct system hardening, vulnerability assessments, and security audits to ensure compliance with industry standards such as information security protocols and cloud security best practices
Oversee system integration efforts utilizing ETL processes, continuous integration/continuous deployment (CI/CD) pipelines, and DevOps methodologies
Manage system administration tasks including network configuration (DNS, DHCP, VPN), firewall setup, load balancing, and system monitoring
Support database management using SQL (MySQL, PostgreSQL, Oracle) and NoSQL solutions for high-volume data storage
Troubleshoot complex issues through debugging techniques across operating systems including Windows, Linux, and UNIX environments
Lead efforts in system documentation, process improvement initiatives, and adherence to the Software Development Life Cycle (SDLC)

Qualification

Requirements engineeringRisk managementVerificationValidationCloud services AWSCloud services AzureProgramming languagesAssay developmentConfiguration managementSystem architectureDatabase management SQLDatabase management NoSQLCross-functional collaborationProblem-solvingEffective communication

Required

3–5 years of experience
Requirement writing experience in a regulated industry (medical device preferred)
Risk analysis experience (FMEA) in an engineering discipline (regulated medical device preferred)
Demonstrated knowledge of systems engineering principles including: Requirements engineering, Tradeoff analysis, Risk management, Configuration management, Verification and validation
Strong ability to work cross-functionally with multiple stakeholders and drive alignment
Bachelor's degree in Computer Science, Systems Engineering, or related field
Proven experience in systems engineering within biotech or laboratory environments
Extensive knowledge of service-oriented architecture (SOA), solution architecture, and system design principles
Proficiency with programming languages such as Python, JavaScript, C#, C++, Ruby on Rails, Bash scripting, and VBA
Strong understanding of computer networking concepts including VPNs, firewalls, DNS, DHCP, load balancing, and threat intelligence
Hands-on experience with cloud platforms like AWS or Azure; familiarity with virtualization technologies such as VMware or ESXi
Knowledge of microservices architecture, REST APIs, SOAP web services, and DevOps tools like Jenkins or Git
Excellent problem-solving skills with the ability to analyze vulnerabilities via vulnerability management tools
Effective communication skills to collaborate across multidisciplinary teams in a fast-paced environment

Preferred

Assay development experience, particularly with cytology specimens
Prior experience using RETINA (Requirements & Test Integration Application)
Experience with LucidSpark/LucidChart
Excellent organizational skills and ability to prioritize multiple projects effectively
Familiarity with laboratory automation systems such as Pegasystems or Salesforce integration

Benefits

Dental insurance
Health insurance
Life insurance
Vision insurance

Company

BEPC Inc. - Business Excellence Professional Consulting

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BEPC Incorporated provides Technical Engineering and Information Technology Project Management services to Fortune 500 companies in the industries: Life Science, Engineering, Manufacturing, Information Technologies, Advanced Technologies, Automotive, and Construction.

H1B Sponsorship

BEPC Inc. - Business Excellence Professional Consulting has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (3)
2020 (3)

Funding

Current Stage
Growth Stage

Leadership Team

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Oscar Casillas
President and CEO
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Andrew Casillas
Human Resources Partner
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Company data provided by crunchbase