Spark Life Solutions Inc · 1 day ago
Senior R&D Engineer
St Paul, MN
Contract
Onsite
Mid, Senior Level
4+ years expSpark Life Solutions Inc is seeking a Senior R&D Engineer to support the design and development of a next-generation large-bore delivery catheter. This role focuses on hands-on mechanical design and ownership of key design control activities, contributing significantly to an upcoming 510(k) submission.
Staffing & Recruiting
Hiring Manager
M D Shanawaz
Responsibilities
Design and develop components and sub-systems for a large-bore delivery catheter
Own major elements of a 510(k) submission targeted for next year
Create and maintain CAD models, 2D drawings, specifications, and BOMs
Perform DFMEAs, tolerance analysis, and GD&T evaluations
Support design controls, risk management, and technical documentation
Drive design improvements through design changes and corrective actions
Collaborate cross-functionally with Quality, Regulatory, and Manufacturing teams
Provide technical mentorship and guidance to junior engineers when required
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field
4+ years of experience in medical device R&D or regulated product development
Strong proficiency with SolidWorks and Windchill
Hands-on experience with: Design controls, GD&T and tolerance analysis, Print packages and technical documentation, Risk management per ISO 14971, Quality systems per ISO 13485
Ability to lead technical work independently with minimal supervision
Preferred
Direct experience with catheter or delivery system development
Prior experience supporting or owning 510(k) submissions
Background in quality integration or design assurance
Company
Spark Life Solutions Inc
Welcome to a partnership focused on excellence.
51-200 employees
H1B Sponsorship
Spark Life Solutions Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (7)
Funding
Current Stage
Growth StageCompany data provided by crunchbase