Spark Life Solutions Inc · 15 hours ago
Senior Mechanical Engineer
Roseville, MN
Contract
Onsite
Mid, Senior Level
3+ years expSpark Life Solutions Inc is focused on integrating Design History Files into their quality system. The Senior Mechanical Engineer will review legacy design documentation and ensure compliance with regulatory and quality standards for a commercial medical device.
Staffing & Recruiting
Hiring Manager
M D Shanawaz
Responsibilities
Convert acquired company Design History Files (DHF) into client-compliant documentation
Review and assess DFMEA, design inputs, and test methods
Perform gap analysis and support closure of documentation and testing gaps
Define, update, and execute design verification and DHF testing
Support test method validation activities
Create and update engineering documentation, including protocols, reports, and traceability matrices
Apply Six Sigma and DMAIC methodologies for problem-solving and risk mitigation
Communicate technical findings, risks, and progress to cross-functional teams and leadership
Qualification
Required
Bachelor's degree in Mechanical, Biomedical, or Electromechanical Engineering
3+ years of experience in Medical Device Engineering
Strong mechanical and systems-level problem-solving skills
Hands-on experience with DHF and DFMEA
Experience with design verification and test method validation
Knowledge of Gauge R&R and statistical analysis using Minitab
Experience with change management and documentation tools (JIRA, Windchill, or similar)
Preferred
Experience with active implantable medical devices
Familiarity with IEC standards (IEC 60601, IEC 14708, IEC 45502)
Experience with statistical analysis and process capability studies
Background in single-use or implantable device testing
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
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Trends of Total Sponsorships
2025 (11)
2024 (7)
Funding
Current Stage
Growth StageCompany data provided by crunchbase