Supira Medical · 12 hours ago
Manufacturing Engineer
Los Gatos, CA
Full-time
Onsite
New Grad, Entry Level
$90K/yr - $115K/yr
0+ years expSupira Medical is a clinical-stage company focused on developing innovative medical devices. The Manufacturing Engineer will contribute to product design, development, manufacturing, and testing while ensuring compliance with the company's Quality System.
Health CareMedicalMedical Device
Hiring Manager
Cole Carnahan
Responsibilities
Work as part of a cross-functional team to develop, optimize, verify, and validate processes through bench, in-vitro, and in-vivo testing
Effectively document work throughout the development process inclusive of lab notebooks, design reviews, Manufacturing Process Instructions (MPIs), equipment qualifications, and process validation
Develop new manufacturing processes as needed, refine the process (through DOE and other methodologies) and implement the process into the production setting
Select and manage critical suppliers and vendors
Develop manufacturing processes by applying engineering knowledge and product design, fabrication, assembly, tooling and materials
Perform process optimization and manufacturing scale-up; develop and implement ergonomic improvements to the process
Improve manufacturing efficiency through planning and evaluation of workflow, space requirements and equipment layout
Research, develop, modify and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R
Prepare production forecasts; manage component and finished good inventory; schedule reorder points
Assure product and process quality by designing test methods, performing process validations and process capability studies
Drive and provide support to quality processes and applying formal problem-solving techniques to determine root cause, and implementing solutions (non-conformance, CAPA, change management, audits, product complaint investigations, etc.)
Provide training to associates, technicians and assemblers; assisting other technical associates
Design and validate fixtures and tools for manufacturing and inspection processes
Design, execute, and analyze experiments using sound statistical methodology. Participate in risk management activities, including development and ownership of process FMEAs
Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation
Support company goals and objectives, policies and procedures, and regulatory requirements (FDA regulations, ISO 13485, MDD, etc.)
Qualification
Required
Bachelor's in Mechanical, Biomedical Engineering or equivalent experience
0 - 3 years of previous medical device experience
Experience developing and executing process and/or equipment validations
Proven ability to prioritize, initiate, and drive projects to completion
Experience with quality system documentation requirements and test protocols
Experience managing production, including creating forecasts and managing inventory
Must be proficient in SolidWorks
Understanding and exposure to principles of product design, manufacturing, risk analysis, and product testing/reporting
Demonstrated ability to apply engineering fundamentals and statistical analysis to manufacturing process trending, improvement and troubleshooting
Benefits
Equity
Benefits
Company
Supira Medical
Supira Medical is a clinical-stage company that develops catheter-based circulatory support devices for patients with heart conditions.
51-200 employees
H1B Sponsorship
Supira Medical 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 (3)
Funding
Current Stage
Late StageTotal Funding
$240.5MKey Investors
Cormorant Asset ManagementThe Capital Partnership
2025-03-26Series E· $120M
2023-11-21Series D· $40M
2022-02-28Series C· $30M
Leadership Team
Nitin Salunke
CEO & President
Recent News
Research & Development World
2025-09-25
Company data provided by crunchbase