Proclinical Staffing ยท 11 hours ago
Senior Product Development Engineer
New York, NY
Full-time
Onsite
Senior Level
5+ years expProclinical Staffing is a specialist employment agency seeking a Senior Product Development Engineer for a successful class II medical device company based in New York. The role involves guiding the design, development, and pilot manufacturing of biologic medical devices while ensuring compliance with regulatory requirements and applying advanced engineering principles.
Staffing & Recruiting
Hiring Manager
Phu Huynh
Responsibilities
Drive the design and development of products and processes, as well as improvements to existing products, ensuring scalability and manufacturability
Develop and conduct the plan for assigned projects, which includes generating prototypes, performing feasibility testing, and refining designs using data-driven approaches
Lead design control activities, including risk management (e.g., FMEAs, HACCP), verification, and validation testing
Design validation protocol and conduct qualification of equipment used under GLP and GMP facility
Create and maintain design history files, technical drawings, and product specifications in compliance with regulatory requirements (FDA, ISO, GMP)
Apply QbD principles to product and process development, ensuring systematic identification of critical quality attributes (CQAs), critical process parameters (CPPs), and risk mitigation strategies
Develop test methods for device performance and characterization testing as well as execute laboratory studies, feasibility testing, and process development experiments
Apply statistical tools for data analysis, product or process characterization, and design of experiments (DOE)
Qualification
Required
Bachelor's degree in biomedical engineering, mechanical engineering or other engineering disciplines, biological sciences or related field, required
5+ years of design/formulation experience in the biotechnology sector with strong fundamental knowledge in GMP
Design and development of bioresorbable medical devices
Proven experience developing medical devices that advanced to commercial release
Preferred
Master's degree in biomedical engineering, mechanical engineering or other engineering disciplines, biological sciences or related field
Company
Proclinical Staffing
At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase