Bachelor's in Mechanical Engineering, Biomedical Engineering, or a related field with 10+ years of medical device experience, or an advanced degree with 9+ years
Proven track record taking designs from concept through commercialization, applying DFX principles to scale
Design expertise in two or more of: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics
Proficiency in SolidWorks, design for manufacturability, tolerance stack analysis, and GD&T
Experience with design of experiments (DOEs) and statistical data analysis; simulation experience (CFD, FEA) a plus
Working knowledge of ISO 13485 and FDA 21 CFR Part 820, plus sterilization and biocompatibility testing in a regulated industry
Experience leading technical teams and mentoring engineers
Strong collaboration, communication, and hands-on problem-solving skills; must comply with applicable vaccination requirements
Responsibilities
Lead design and development of new single-use devices and accessories, serving as technical lead and, when needed, core team lead
Keep all design work compliant with design controls, partnering cross-functionally to ensure manufacturability, reliability, and scalability
Build prototypes, design fixtures, run feasibility studies, and execute testing to guide product decisions
Solve engineering problems through root cause analysis and data-driven methods
Define and lead qualification strategies for new designs and processes, aligning with teams across the organization
Translate customer needs into product requirements and engineering specifications
Develop test methods, write and execute protocols, and author reports and risk documentation
Manage suppliers and coordinate external sterilization, packaging, and biocompatibility testing; communicate progress, results, and risks to stakeholders
Numbers & Facts
Location
Pleasanton, CA
Skills
Biomedical Engineeringunmatched
Catheterizationunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Constructionunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Documentationunmatched
Electromechanical Systemsunmatched
Experiment Designunmatched
FDA (Food and Drug Administration)unmatched
Feasibility Analysisunmatched
Finite Element Analysisunmatched
Geometric Dimensioning and Tolerancingunmatched
ISO (International Organization for Standardization)unmatched
Injection Moldingunmatched
Leadershipunmatched
Manufacturing Designunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Mentoringunmatched
Problem Solving Skillsunmatched
Product Documentationunmatched
Product Engineeringunmatched
Product Testingunmatched
Prototypingunmatched
Quality Assurance Methodologyunmatched
Reporting Skillsunmatched
Research & Development (R&D)unmatched
Riskunmatched
Root Cause Analysisunmatched
Sales Qualificationunmatched
Simulationunmatched
SolidWorksunmatched
Statisticsunmatched
Sterilizationunmatched
Team Lead/Managerunmatched
Technical Leadershipunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Tolerance Analysisunmatched
Vendor/Supplier Managementunmatched
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