Product Engineer

Responsibilities

• Decomposing system level requirements to mechanical product design definition, analysis and problem solving
• Architect layout and detailed sub-assemblies and components design
• Design qualification and test activities
• Collaboration/coordination/leading with other cross-functional team members to integrate the product and realize the functionality and performance
• Interpret requirements and rationalize the design choices with the multi-disciplinary team
• Leverage quantitative approaches and knowledge of both mechanical design and manufacturing considerations
• Develop and evaluate engineering prototypes
• Work with external suppliers, qualify and select optimal parts

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar
• Minimum of 5 years of post-educational professional experience
• Graduate degree in Mechanical Engineering, Biomedical Engineering or similar preferred
• Minimum of 8-10 years of post-educational experience in Medical Device Design preferred
• Experience with design best practices, including advanced tolerance design, design for reliability, and design for reusability
• Experience with design for Six Sigma, Design for Manufacturability training / experience
• Experience with injection molded plastics and design of high-volume disposables
• Experience as mechanical lead in the development of high volume disposables
• Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies
• Expertise in common risk management techniques (FMEA, FTA, ETA)
• Experience in modeling, simulations and sensitivity analyses
• Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR, ISO 13845, ISO 14971 and IEC 60601 and collateral standards

Qualifications

• Excellent written & verbal communication skills
• Sound management skills driving projects and tactfully leading teams to achieve goals
• Minimal direction with the ability to learn and adapt quickly to new technologies and trends
• Strong organization and coordination skills
• Demonstrated customer focus, track record of innovation and publication
• Must be comfortable making practical assumptions with engineering justifications, where needed
• Able to work independently
• Able to work under pressure and time constraints
• Effective interpersonal and collaborative skills