Design Lead

Job Summary

• Performs layout, construction and evaluation of fixtures and development tools

• Provides technical support services at the direction of senior engineers and scientists

• Conducts engineering evaluations, feasibility studies, and functional testing

• Performs troubleshooting and fault isolation on breadboards, hybrids, and prototype hardware

• Executes design verification testing, documents and tabulates results, and prepares engineering test reports

• Prepares and maintains technical documentation, including specifications, schematics, and mechanical layouts

• Applies engineering and scientific principles to analyze and resolve technical problems

• Exercises technical judgment in planning, organizing, and executing engineering tasks

• Ensures compliance with FDA regulations, company policies, and quality procedures

• Maintains effective communication and collaboration with internal teams, contractors, vendors, and customers

• Utilizes production equipment, test instruments, precision measurement tools, and standard office software as required

• Stays current with technical advancements and best practices, and applies cost-effective solutions

• Performs additional assigned engineering duties as needed

Key Responsibilities

• Strong understanding of design concepts, prototyping, and hardware systems

• Proficiency in troubleshooting, fault isolation, and debugging electronic hardware

• Ability to perform engineering testing, validation, and data analysis

• Familiarity with test equipment and precision measurement instruments

• Working knowledge of manufacturing processes and quality systems (optional)

Skill Requirements

• Strong analytical thinking and problem-solving capability

• Effective written and verbal communication across multiple organizational levels

• Ability to work both independently and within cross-functional teams

• Strong organizational skills, attention to detail, and follow-up discipline

• Ability to engage stakeholders and collaborate to achieve project objectives

Other Requirements

• Bachelor’s degree in Electrical/Electronic Engineering or related field

• Minimum 3 years of relevant experience in test equipment design, construction, and evaluation

• Demonstrated ability to comply with FDA regulations and company processes

• Ability to work in a fast-paced and geographically distributed environment

• Strong ability to multitask, prioritize, and meet deadlines

• Experience in a regulated industry environment (e.g., medical devices)

• Experience working in a cross-functional or matrixed organization

• Experience with manufacturing processes and methods, especially in medical devices (optional)

• Six Sigma knowledge or certification (optional)

• Advanced certification or credential in a relevant discipline (optional)

• Ability to travel up to ~10% (including international) (optional)