Design Engineer Jobs

Description

Participate in all aspects of product, process, and design development in order to ensure the highest level of quality in new products, and their compliance to applicable regulations and standards.

Responsibilities

• Participate in the creation or modification or review of Design Input, Design Output, Design Verification, Design Validation, and Risk Management FMEA Report.
• Performs special projects as assigned including RMA process.
• Supporting the logistics and supply chain functions to ensure compliance within designated projects and product lines.
• Apply Design Control principles to positively influence new product development efforts.
• Work with Director of Operations and Senior Operations Manager to continually improve process capabilities, product reliability, and incoming inspections to meet our quality standards.
• Assist in creation and implementation of risk analysis documentation for new products with identified hazards and harms.
• Apply statistical rationale to plan, analyze, and interpret engineering test data collected during Design Verification Testing.
• Represent Design Engineering on cross-functional teams, interfacing among multiple departments and teams such as Operations and Planning/Manufacturing, and R&D.
• Create engineering change orders on assigned projects and products.
• Plan, design, and implement test methods and test equipment for product inspection.

Qualifications

• Experience in Design for Manufacturability (DFM), Design for Assembly (DFA), statistical tolerance analysis techniques, functional dimensioning, and geometric tolerancing.
• Bachelor’s degree in engineering (mechanical, biomedical, or materials preferred).
• Experience with 3D CAD tools, specifically Solidworks,
• Working knowledge of data collection, data analysis and statistical techniques.
• Experience with precision parts and component design.
• 3+ years of hands-on mechanical product design engineering.
• Good knowledge of Design Controls and Risk Management for medical devices.
• Critical thinking skills and good judgment.
• 2 – 5 years of experience in a design engineering role in medical devices.
• Excellent, proven interpersonal, verbal and written communication skills.