Katalyst CRO
Posted 60 days agoVerified live 2d ago
R&D Engineer
Brief overview
Remote
UndergradOr in progress
3+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Product DesignPrototype DevelopmentEngineering DocumentationSolidWorksCreoCATIAAutoCADSiemens NXDesign Verification & Validation (V&V)Design ControlsRisk ManagementDesign ReviewsProcess Validation (IQ/OQ/PQ)Statistical AnalysisMinitabJMPDesign 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 seeking an innovative and detail-oriented R&D Engineer to support the research, design, development, and validation of new products and technologies. The ideal candidate will collaborate with cross-functional teams to transform concepts into commercially viable products while ensuring compliance with quality, regulatory, and customer requirements.
Responsibilities
- Design, develop, and improve new products, components, and manufacturing processes
- Support all phases of product development, from concept through commercialization
- Create engineering drawings, specifications, and technical documentation
- Develop prototypes and conduct feasibility studies to evaluate product performance
- Plan and execute design verification and validation (V&V) testing
- Perform root cause analysis and implement corrective actions for product and process issues
- Conduct Design Failure Mode and Effects Analysis (DFMEA), Process FMEA (PFMEA), and risk assessments
- Collaborate with Manufacturing, Quality, Regulatory, Supply Chain, and Operations teams to support design transfer and production readiness
- Support process validation activities, including IQ/OQ/PQ, as required
- Analyze test data and prepare engineering reports and technical presentations
- Ensure compliance with applicable industry standards, regulatory requirements, and company quality systems
- Drive continuous improvement initiatives to enhance product quality, reliability, and manufacturability
- Participate in design reviews, technical risk assessments, and engineering change activities
Skills
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline
- 3–8+ years of experience in Research & Development, Product Development, or Design Engineering
- Experience with product design, prototype development, testing, and engineering documentation
- Proficiency in CAD software such as SolidWorks, Creo, CATIA, AutoCAD, or Siemens NX
- Strong understanding of engineering principles, materials, and manufacturing processes
- Experience with Design Verification & Validation (V&V)
- Knowledge of Design Controls, Risk Management, and Design Reviews
- Strong analytical, problem-solving, and troubleshooting skills
- Excellent written and verbal communication skills
- Ability to work effectively in a cross-functional team environment
- Experience in Medical Devices, Biotechnology, Life Sciences, Aerospace, Automotive, Consumer Products, or Advanced Manufacturing
- Knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, ISO 14971, or ISO 9001 (depending on industry)
- Experience with statistical analysis tools such as Minitab or JMP
- Familiarity with DOE (Design of Experiments), GD&T, tolerance analysis, and DFM/DFA principles
- Experience supporting New Product Introduction (NPI) and design transfer activities
Qualifications
Must Haves
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline
- 3–8+ years of experience in Research & Development, Product Development, or Design Engineering
- Experience with product design, prototype development, testing, and engineering documentation
- Proficiency in CAD software such as SolidWorks, Creo, CATIA, AutoCAD, or Siemens NX
- Strong understanding of engineering principles, materials, and manufacturing processes
- Experience with Design Verification & Validation (V&V)
- Knowledge of Design Controls, Risk Management, and Design Reviews
- Strong analytical, problem-solving, and troubleshooting skills
- Excellent written and verbal communication skills
- Ability to work effectively in a cross-functional team environment
Nice to Haves
- Experience in Medical Devices, Biotechnology, Life Sciences, Aerospace, Automotive, Consumer Products, or Advanced Manufacturing
- Knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, ISO 14971, or ISO 9001 (depending on industry)
- Experience with statistical analysis tools such as Minitab or JMP
- Familiarity with DOE (Design of Experiments), GD&T, tolerance analysis, and DFM/DFA principles
- Experience supporting New Product Introduction (NPI) and design transfer activities