Position Summary
The Staff, Supplier Engineer will lead the transfer, scale-up, and continuous improvement of manufacturing processes for medical device products. This role serves as the technical lead for contract manufacturers and suppliers, supporting process development, validation, quality, and cost improvement in a regulated environment.
Key Responsibilities
-
Act as the primary technical contact for contract manufacturers and suppliers
-
Lead process transfer from R&D to pilot and full production
-
Develop, validate, and improve manufacturing processes and equipment
-
Plan and execute process validations (IQ/OQ/PQ) and maintain validation documentation
-
Create and maintain process risk tools such as PFMEA
-
Support supplier selection, qualification, and capacity planning
-
Drive process improvement, yield enhancement, and cost reduction initiatives
-
Apply lean manufacturing principles to improve flow, efficiency, and quality
-
Collaborate with R&D on design for manufacturability (DFM)
-
Develop tooling, fixtures, work instructions, and inspection plans
-
Lead root cause investigations and corrective actions for manufacturing issues
-
Ensure compliance with FDA, ISO, and quality system requirements
-
Support new product introductions and production ramp-ups
-
Travel occasionally to supplier and manufacturing sites
Qualifications
-
Bachelor’s degree in Mechanical Engineering or related field (Master’s preferred)
-
8+ years of manufacturing/process engineering experience in medical devices or high-volume production
-
Strong experience with process development, validation, and supplier transfer
-
Knowledge of FDA, ISO, and regulated manufacturing environments
-
Experience with lean manufacturing and continuous improvement tools
-
Strong problem-solving and statistical analysis skills (DOE, Cpk, GR&R)
-
Excellent communication and project management skills
Preferred Experience
-
Catheter, balloon, or stent manufacturing
-
Braiding, coiling, or laser processing
-
Tooling and fixture design
-
SolidWorks proficiency
Benötigen Sie weitere Hilfe? Greifen Sie zu an einen unserer Mitarbeiter.
Wir sind ein vertrauenswürdiger Partner für jeden Schritt von der Entdeckung bis zur Entwicklung. Egal, wo Sie sich auf Ihrer Reise befinden, wir sind hier, um Ihnen zu helfen, etwas zu bewirken. Wir sind ein vertrauenswürdiger Partner für jeden Schritt von der Entdeckung bis zur Entwicklung. Egal, wo Sie sich auf Ihrer Reise befinden, wir sind hier, um Ihnen zu helfen, etwas zu bewirken. an einen unserer Mitarbeiter.
