Katalyst CRO
Posted 20 days agoVerified live 2d ago
Systems Engineer (medical devices)
Brief overview
Remote
UndergradOr in progress
3+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Systems Engineering PrinciplesElectro-mechanical SystemsSoftware-integrated SystemsRequirements ManagementTraceabilityRisk ManagementReliability EngineeringCybersecurity ConceptsDOORSTeamcenterTrackWise8JIRAALMSysMLUMLStatistical MethodsDesign of Experiments (DOE)
About the company
Katalyst CROkatalysthls.com
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
Visa sponsorship history
4 years sponsoring, last filed FY2026
Data powered by U.S. Department of Labor. This does not guarantee sponsorship for this specific role.32H-1B approved
89%approval rate
3new H-1B hires
9PERM certified
$240,000median wage / yr
H-1B Petition ApprovalsVisas USCIS actually granted: the strongest sign the company sponsors.
202319
20249
20254
LCA Certified ApplicationsAn early filing step, not a visa approval: it signals intent, not confirmed sponsorship.
20236
20242
20259
20262
Green Card (PERM) FilingsCertified green card filings: a long-term commitment to international hires.
20235
20241
20253
Top sponsored roles
VALIDATION ENGINEERQUALITY ENGINEERCLINICAL DATA ANALYSTPRODUCT DEVELOPMENT ENGINEERCLINICAL DATA MANAGER
Sponsored employees from
India
Job description
Summary
Katalyst CRO is a company focused on supporting the technical direction of Acute Therapies products. The Systems Engineer will contribute to the full product development lifecycle, emphasizing requirements management, risk analysis, system integration, and verification/validation within a regulated medical device environment.
Responsibilities
- Support systems engineering activities across all product lifecycle stages (NPD to post-market)
- Translate clinical and user needs into product requirements
- Gather and manage requirements from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)
- Drive system-level design and product realization using engineering best practices
- Develop design concepts and research methodologies aligned with business and user needs
- Create and maintain Design History File (DHF) documentation
- Ensure traceability between requirements, risks, and verification activities
- Identify technical risks early and implement mitigation strategies
- Perform system integration, verification, and validation activities
- Conduct root cause analysis using tools like fishbone diagrams, Pareto charts, etc
- Assess impact of design/process/material changes and recommend solutions
- Collaborate and influence cross-functional teams and stakeholders
- Ensure compliance with FDA, ISO, and IEC design control standards
- Utilize tools/software to support engineering and documentation activities
Skills
- Strong understanding of systems engineering principles
- Experience with electro-mechanical and/or software-integrated systems
- Knowledge of requirements management and traceability
- Familiarity with risk management and reliability engineering
- Hands-on with tools such as: DOORS, Teamcenter, TrackWise8, JIRA / ALM
- Working knowledge of SysML or UML
- Understanding of statistical methods (DOE, sampling, etc.)
- Strong analytical, problem-solving, and communication skills
- Ability to work independently and manage multiple priorities
- Experience in medical devices, especially ICU or kidney care products
- Background in regulated industries (medical, aerospace, automotive, military)
- Experience working with global, cross-functional teams
- Bachelor's or Master's degree in: Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering (or related field)
- 3+ years of relevant experience
- Experience with connected devices / cybersecurity concepts
Qualifications
Must Haves
- Strong understanding of systems engineering principles
- Experience with electro-mechanical and/or software-integrated systems
- Knowledge of requirements management and traceability
- Familiarity with risk management and reliability engineering
- Hands-on with tools such as: DOORS, Teamcenter, TrackWise8, JIRA / ALM
- Working knowledge of SysML or UML
- Understanding of statistical methods (DOE, sampling, etc.)
- Strong analytical, problem-solving, and communication skills
- Ability to work independently and manage multiple priorities
- Experience in medical devices, especially ICU or kidney care products
- Background in regulated industries (medical, aerospace, automotive, military)
- Experience working with global, cross-functional teams
- Bachelor's or Master's degree in: Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering (or related field)
- 3+ years of relevant experience
Nice to Haves
- Experience with connected devices / cybersecurity concepts