Spark Life Solutions Inc · 18 hours ago
Manufacturing Engineer
California, United States
Contract
Onsite
Senior Level
6+ years expSpark Life Solutions Inc is seeking an experienced Manufacturing Engineer to support process development, validation, and production in a regulated medical device environment. The role involves leading process and equipment validation, supporting new product introduction, and ensuring compliance with industry regulations.
Staffing & Recruiting
Hiring Manager
M D Shanawaz
Responsibilities
Lead process and equipment validation (IQ/OQ/PQ)
Support new product introduction, technology transfer, and production scale-up
Develop and maintain manufacturing documentation (protocols, SOPs, reports)
Perform risk management activities (PFMEA) and statistical analysis (GR&R, Cpk, Ppk)
Lead CAPA, deviation investigations, and root cause analysis (8D, 5-Why)
Ensure compliance with FDA 21 CFR 820 and ISO 13485
Drive continuous improvement using Lean/Six Sigma tools
Collaborate with Quality, R&D, and Operations teams
Qualification
Required
Bachelor's in Engineering or related field
6+ years in medical device manufacturing engineering
Strong knowledge of GMP, process validation, and quality systems
Strong documentation and communication skills
Preferred
Experience with plastic molding or automated assembly lines preferred
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