Associate Engineer

POSITION SUMMARY:

The Associate Engineer supports the design, development, testing, manufacture, and ongoing improvement of medical device products and processes under the guidance of more senior engineering staff. This position applies foundational engineering principles, data analysis, and structured problem-solving to complete technical assignments, maintain accurate documentation, and contribute to cross-functional project teams. The Associate Engineer works collaboratively with Engineering, Quality, Manufacturing, Regulatory, suppliers, and other partners to support product quality, patient safety, and business objectives. 

ESSENTIAL FUNCTIONS OF THE POSITION:

• Contribute to engineering projects involving product design, process development, manufacturing support, quality, and continuous improvement. 
• Perform technical research, analysis, calculations, and testing in support of new and existing products and processes. 
• Assist with the design, build, evaluation, and refinement of components, assemblies, prototypes, fixtures, tooling, test methods, or manufacturing processes. 
• Develop and maintain engineering documentation, which may include requirements, specifications, drawings, bills of material, risk documents, work instructions, test protocols, reports, and change records. 
• Plan and execute assigned testing using appropriate equipment and sound experimental methods; collect, organize, analyze, and interpret data and communicate conclusions and recommendations. 
• Support verification, validation, qualification, and design transfer activities in accordance with applicable procedures and project requirements. 
• Provide technical support for product or process issues through observation, troubleshooting, root cause investigation, and implementation of appropriate corrective or preventive actions. 
• Collaborate with cross-functional teams and external suppliers to resolve technical issues, meet project objectives, and support timely completion of deliverables. 
• Participate in design reviews, risk management activities, process reviews, and other technical discussions as assigned. 
• Identify opportunities to improve product quality, reliability, manufacturability, efficiency, consistency, capacity, or cost. 
• Use engineering tools, statistical methods, and problem-solving techniques appropriate to the assignment. 
• Complete work in compliance with the company quality system, applicable regulations, standards, and documented procedures. 
• Organize and prioritize assigned tasks, communicate status and risks, and complete deliverables in alignment with project schedules and team objectives. 
• Perform work independently within defined assignments and seek guidance from senior engineers or management when needed. 

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree in engineering or a related technical discipline 
• Entry-level engineering experience; relevant internship, co-op, academic project, or laboratory experience
• Foundational knowledge of engineering principles, product development, manufacturing methods, or quality systems 
• Ability to read and interpret technical specifications, drawings, procedures, and test requirements 
• Demonstrated ability to collect and analyze data, solve problems, and troubleshoot technical issues 
• Ability to prepare clear and accurate technical documentation, including test plans, reports, specifications, or work instructions 
• Effective written and verbal communication skills 
• Ability to work effectively in a collaborative, cross-functional team environment 
• Strong attention to detail, organization, and ability to manage multiple priorities 
• Proficiency with standard computer applications and the ability to learn role-specific engineering tools 

PREFERRED QUALIFICATIONS:

• Engineering degree in Biomedical, Mechanical, Electrical, Industrial, Manufacturing, or a related discipline 
• Experience in medical devices, life sciences, or another regulated industry 
• Understanding of design controls, risk management, verification and validation, quality controls, or manufacturing process controls 
• Experience with statistical analysis, design of experiments, process capability, or other data analysis methods 
• Experience with CAD, laboratory equipment, test equipment, metrology tools, programming, or engineering analysis software relevant to the assigned function 
• Familiarity with FDA quality system requirements, ISO 13485, or other applicable medical device standards 
• Hands-on experience with prototype development, product testing, manufacturing support, or process improvement 

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to occasionally lift up to 25
• Ability to pass pre-employment drug screen and background check

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