Spark Life Solutions Inc · 3 hours ago
Principal Mechanical Engineer
Waltham, MA
Contract
Onsite
Lead/Staff
8+ years expSpark Life Solutions Inc is seeking an experienced Principal Mechanical Engineer to support the design and development of medical device products. This role requires strong hands-on mechanical design expertise and the ability to lead technical efforts across cross-functional teams.
Staffing & Recruiting
Hiring Manager
M D Shanawaz
Responsibilities
Lead mechanical design and development of medical devices from concept through production
Create and review detailed 3D CAD models and 2D drawings using SolidWorks
Drive design reviews, tolerance analyses, and risk assessments (DFMEA)
Collaborate with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory
Support prototype builds, testing, and validation activities (DV & PV)
Ensure designs comply with FDA regulations, ISO standards, and internal quality systems
Mentor junior engineers and provide technical leadership on complex projects
Interface with suppliers and manufacturing partners to support design for manufacturability (DFM) and assembly (DFA)
Support documentation required for design history files (DHF) and engineering change orders (ECOs)
Qualification
Required
Bachelor's degree in Mechanical Engineering (BSME)
8–10 years of hands-on mechanical engineering experience in the medical device industry
Strong proficiency in SolidWorks (CSWA or CSWP preferred)
Experience working in a regulated environment (FDA, ISO 13485)
Solid understanding of design controls, verification, and validation processes
Experience with material selection, tolerance stack-ups, and GD&T
Strong communication and technical documentation skills
Preferred
Master's degree in Mechanical Engineering (MSME)
SolidWorks certification (CSWA/CSWP)
Experience leading or owning mechanical subsystems or full product designs
Prior experience supporting products through manufacturing transfer
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