Suru · 16 hours ago
Principal Product Development Engineer
Suru is seeking a Principal Product Development Engineer specializing in mechanical engineering for catheter-based medical devices in interventional radiology. The role involves leading the design and optimization process from concept to production, ensuring compliance and manufacturability while collaborating with cross-functional teams.
Responsibilities
Translate user needs and system requirements into clear, testable mechanical specifications
Develop catheter and Interventional Radiology focused product architectures; drive concepts into detailed design and commercialization
Build high-fidelity 3D models (SolidWorks required); generate drawings, GD&T, tolerance analyses, BOMs, and design documentation
Perform DFMEA, risk analysis, tolerance/statistical analyses, and impact assessments
Conduct FEA to assess structural integrity and device performance
Design components using plastics and injection-molding principles; collaborate with molding engineers to ensure manufacturability
Lead root-cause investigations and implement corrective design actions
Drive design reviews and ensure alignment with DFMA principles and design control standards
Partner with suppliers to source prototypes, assess feasibility, and integrate feedback
Support verification and validation efforts, including Engineering Confidence Testing
Communicate effectively across cross-functional teams and take ownership of project-level technical leadership
Qualification
Required
BSME
10+ years' mechanical product development experience in interventional radiology or catheter-based Class II/III devices (100% required)
10+ years of 3D design experience in SolidWorks
Strong capability in GD&T, tolerance stacks, and detailed mechanical drafting
Experience designing components that incorporate plastics/injection-molded parts
DFMEA and root-cause analysis expertise
Hands-on DFM/DFA experience and familiarity with materials selection
Strong communication skills, cross-functional leadership traits, and experience owning design activities—not project management, but true technical leadership
Preferred
MSME
Experience with biopsy, vascular access, oncology-targeted, or other IR-related devices
Company
Suru
Suru is a specialized recruiting firm focused on delivering top-tier talent for direct hire and temporary placements across a wide range of industries.
Funding
Current Stage
Early StageCompany data provided by crunchbase