OrganOx · 8 hours ago
Product Engineer
Madison, NJ
Full-time
Onsite
Mid Level
$115K/yr - $130K/yr
3+ years expOrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The R&D Product Engineer is responsible for engineering changes affecting the full life cycle of the metra platform, focusing on requirements and design history file management.
Health CareMedicalMedical Device
Responsibilities
Review design history file deliverables and records and identify opportunities for improvement
Writing and maintaining engineering documentation, including product specifications including flow down from user needs to system subsystem and module level and other device history file deliverables
Working on problems for production support, quality improvements, and line extensions. This includes conducting and supporting problem solving efforts and root cause analysis, CAPA ownership, and identification and evaluation of potential solutions
Interpreting and understanding the product's intended use, clinical procedures, customer needs and design inputs
Verification and Validation Testing: Conduct thorough testing to verify that the system meets functional requirements and validate their performance against clinical needs including hardware and embedded systems (firmware) functionality
Risk Management: Identify and mitigate potential safety risks throughout the design process through FMEA analysis and risk assessment
Regulatory Compliance: Adhere to relevant regulatory standards (e.g. IEC 60601-1, IEC 62368-1, or equivalent) for medical devices, including documentation and reporting requirements
Prepare visualizations and conclusions for presentation to upper management
Demonstrating ownership and integrity of work, a spirit of volunteerism, a passion for excellence and our products, and a hands-on approach to engineering
Qualification
Required
Bachelor's Degree in Engineering (such as Biomedical, Electrical, Systems or Software)
3+ years of work experience in design/new product development
Experience with DHF maintenance/deliverable authorship
Drafting and reviewing system requirements from user needs through subsystems and module level
Experience with specification and test of electromechanical systems
Preferred
Medical device industry experience
Previous experience in medical devices under ISO 13485 QMS
Supplier management including component obsolescence management
Experience as CAPA owner
Benefits
Health
Dental
Vision
Disability coverage
Flexible spending accounts
401(k)-retirement plan with company matching after 90 days
Paid time off
Holidays
Additional leave benefits
Employee discounts
Access to our onsite wellness facility
Company
OrganOx
OrganOx is a medical technology company.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$206.97MKey Investors
HealthQuest CapitalLauxera Capital PartnersBusiness Growth Fund
2025-08-23Acquired
2025-02-24Series Unknown· $160M
2025-02-24Secondary Market
Leadership Team
Steve Deitsch
CFO
Recent News
Medical Device Network
2026-01-07
2025-12-10
Company data provided by crunchbase