Systems Engineer / Senior Systems Engineer responsible for V-Model systems engineering outputs, design reviews, development, testing, and documentation in a biotech environment.
Responsibilities
Deliver V-Model systems engineering outputs and participate in design reviews.
Conduct development and testing to evaluate performance against design specifications and system interactions.
Ensure assays operate efficiently and effectively using the latest technologies and systems.
Execute project deliverables—including requirements, risk, configuration management, defect management, and verification and validation—within the company-specific tool.
TMV, Test Method Development, DoE, data analysis (python coding capability).
Requirements
Bachelor's degree in Engineering (Electrical, Chemical, Biomedical, or Software)
Nice to have: FDA or FAA regulated environment experience
Nice to have: Medical device industry experience
Nice to have: Translating industry standards
Nice to have: Interpreting and tracing legal, safety, and industry regulations
Deliver V-Model systems engineering outputs and participate in design reviews, conducting development and testing to evaluate performance against design specifications and system interactions.
Compensation
$45 –$60/hour (W2)
Responsibilities
Deliver V-Model systems engineering outputs and participate in design reviews
Conduct development and testing to evaluate performance against design specifications and system interactions
Ensure assays operate efficiently and effectively using the latest technologies and systems
Execute project deliverables—including requirements, risk, configuration management, defect management, and verification and validation—within the company-specific tool
Test Method Development, DoE, data analysis (python coding capability)
Requirements
Bachelor's degree in engineering (Electrical, Chemical, Biomedical, or Software preferred)
Nice to have: FDA regulated environment experience
Nice to have: FAA regulated environment experience
Deliver V-Model systems engineering outputs and participate in design reviews. Conduct development and testing to evaluate performance against design specifications and system interactions. Ensure assays operate efficiently and effectively using the latest technologies and systems.
Responsibilities
Deliver V-Model systems engineering outputs and participate in design reviews
Conduct development and testing to evaluate performance against design specifications and system interactions
Ensure assays operate efficiently and effectively using the latest technologies and systems
Execute project deliverables—including requirements, risk, configuration management, defect management, and verification and validation—within the company-specific tool
TMV, Test Method Development, DoE, data analysis (python coding capability)
Requirements
Bachelor's degree in Engineering (Electrical, Chemical, Biomedical, or Software preferred)
Lead test engineering for wireless diabetes therapy systems, developing test strategies, plans, and methods, and executing verification and validation activities.
Compensation
Salary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00
For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000 - $165,000 USD.
Responsibilities
Develop test strategies for insulin therapy systems
Lead experimental fluid mechanics and flow diagnostics research, develop new test systems, methods, and digital tools for cardiac surgery applications.
Compensation
For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).
Responsibilities
Innovate, develop, and qualify new test systems, methods, SOPs, R&D processes, analytics routines, and engineering models
Create, evaluate, and improve products as part of cross-functional New Product Development teams
Advance laboratory data and digital capabilities through automation, programming, data integration, and development of efficient engineering analysis workflows
Develop and execute engineering project plans
Support design control activities including requirements, risk documentation, and technical documentation
Requirements
Bachelor's Degree in Engineering or Scientific field
Master's Degree in Engineering or Scientific field
Ph.D. in Engineering or Scientific field
Nice to have: heart valve performance or related biomedical applications
For California, the base pay range for this position is $108,000 to $153,000 (highly experienced).
Responsibilities
Collaborate with Clinical Development group to develop Statistical Shape Models for patient anatomy for implant, access and DS.
Collaborate with Clinical Development group and R&D group to develop boundary conditions.
Lead effort to develop FEA models for components and systems for access and DS products.
Support other FEA engineers in developing, modifying FEA for THV frames.
Lead effort to develop virtual and bench models like sample holders, clinically accurate compliant aortic roots, vessels, CAD and manufacturing (machining, molding).
Requirements
Bachelor's Degree in Engineering or Scientific field
Master's Degree in Engineering or Scientific field
Nice to have: 2+ years of experience in the medical device industry
Nice to have: 6+ years of experience in simulation using FEA with commercially available software
Responsible for development and release of bulk materials, focusing on 2K structural adhesives and foams for Ford battery electric vehicle manufacturing.
Compensation
This position is a salary grade 5 and ranges from $65,100-$109,300
This position is a salary grade 6 and ranges from $74,300-$124,500
This position is a salary grade 7 and ranges from $86,600-$144,900
This position is a salary grade 8 and ranges from $99,100-$166,200
Responsibilities
Develop and manage materials engineering foundation documents
Support development material FEDE requirements and Design Rules
Review and signoff on engineering drawings and BOMs in TeamCenter
Provide root cause analysis and materials expertise for manufacturing and field issues
Support manufacturing site assessments and process development
Requirements
Bachelor of Science in Material Science & Engineering
Bachelor of Science in Materials Engineering
Bachelor of Science in Chemical Engineering
Bachelor of Science in Chemistry
Nice to have: Master of Science in Material Science & Engineering