Carlsmed · 19 hours ago
Sr. Manufacturing Engineer
Carlsbad, California, United States
Full-time
Onsite
Mid, Senior Level
$125K/yr - $145K/yr
5+ years expCarlsmed is dedicated to improving healthcare outcomes for spine surgery through their innovative platform. The Sr. Manufacturing Engineer will support the Advanced Manufacturing & Technology team by designing, validating, and maintaining production processes for personalized devices, while also collaborating with various teams to enhance product quality and efficiency.
Health CareManufacturingMedical Device
Responsibilities
Develop new/improve existing manufacturing processes for novel patient-specific products
Transfer products and concepts from engineering to manufacturing to ensure seamless product scaling
Conduct DFAM (Design for Additive Manufacturing) analysis for NPI (new product introduction) and modifications to existing products
Define best practices for build prep, support strategy, thermal management etc…
Lead process efficiency initiatives, identify bottlenecks and implement improvements
Own and drive pFMEA (Process Failure Modes and Effects Analysis)
Author and approve validation documentation including IQ/OQ/PQ protocols, test methods, reports, sampling rationales, and traceability matrices
Manage vendor relationships and work closely with vendors to aid in process/design transfer
Support the Quality team in maintaining/developing Cleaning, Packaging and Sterilization processes
Manage product/process changes through change control, assess impacts, and define revalidation requirements
Define worst-case selection, acceptance criteria, sampling methods and testing coordination
Provide support for investigations, nonconformances, and process troubleshooting (FMEA, NCRs, CAPAs)
Qualification
Required
Education: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science or equivalent
Experience: 5-8 years of relevant engineering experience in a regulated environment required
Technical Expertise in LPBF (Laser Powder Bed Fusion)
Experience with nTop, Materialise and Python programming
Experience with CAD software (Onshape, SolidWorks, Creo)
Expertise in interpreting documents such as drawings, safety rules, company policy and industry regulations/standards
Familiarity with sterilization and cleaning validation for medical devices
Excellent verbal and written communication
Ability to perform high quality work with speed
Willingness to wear multiple hats when needed to enable excellent patient outcomes
Ability to translate requirements into functional solutions
Strong technical writing, and ability to translate requirements into clear concise documentation
Proficiency with Microsoft Office with a strong ability to write business reports and correspondence
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13584
Preferred
Experience with spine or orthopedics highly desired
Strong understanding of ISO 13485 and FDA requirements for quality systems and medical devices
Understanding of product design controls and risk management (ISO 14971)
Experience scaling LPBF into serial production environment
Benefits
100% of monthly healthcare, dental and vision insurance premiums
A 401(k) plan with employer matching
Unlimited PTO
Company
Carlsmed
Carlsmed manufactures and sells digital-to-device 3-D printed implant system for lumbar spine surgery.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$108.98MKey Investors
B Capital,U.S. Venture PartnersB CapitalU.S. Venture Partners
2025-07-23IPO
2024-03-18Series C· $64.5M
2022-04-19Series B· $30M
Leadership Team
Michael Cordonnier
Chairman, CEO and Co-Founder
Niall Casey
CIPO, CTO, Co-founder, Board Member
Recent News
2026-01-23
2026-01-13
2026-01-12
Company data provided by crunchbase