DESIGN AND DEVELOPMENT ENGINEER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Published: October 11, 2024 - The Design and Development Engineer possesses extensive experience in leading key project and product development activities in the implantable medical device sector. Demonstrates strong project management skills, adept at creating detailed protocols, authoring comprehensive reports, and writing manufacturing procedures aligned with FDA Quality regulations. Expert in using SolidWorks for design and PDM, capable of solving technical problems efficiently to meet device requirements and project timelines.

Essential Hard and Soft Skills for a Standout Design and Development Engineer Resume
  • CAD Software Proficiency
  • Programming
  • Finite Element Analysis
  • 3D Printing and Prototyping
  • PDM Software
  • Electrical Circuit Design
  • Mechanical Simulation
  • Project Management Tools
  • Manufacturing Process Knowledge
  • Regulatory Compliance
  • Critical Thinking
  • Problem-Solving
  • Effective Communication
  • Leadership
  • Time Management
  • Team Collaboration
  • Adaptability
  • Creativity
  • Attention to Detail
  • Stress Management

Summary of Design and Development Engineer Knowledge and Qualifications on Resume

1. BS in Mechanical Engineering with 4 Years of Experience

  • Experience in leading key project/product development activities
  • Experience creating protocols and authoring reports.
  • Demonstrated project/program management experience with implantable medical device R&D and / or manufacturing working with internal and external customers
  • Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality
  • Ability to solve technical problems, implementing practical solutions based on device requirements and project timelines
  • Working knowledge of FDA Quality regulations related to implantable medical devices
  • Experience writing manufacturing procedures.
  • Risk analysis experience
  • SolidWorks design and PDM experience
  • Experience with LabVIEW or Minitab

2. BS in Electrical Engineering with 5 Years of Experience

  • CNC programming experience
  • Experience working with Design History files from prototype to market release for medical devices.
  • Experience working on DFMEA and PFMEA activities for new medical device products to improve design and process performances
  • Experienced with Geometric Dimensioning and Tolerancing, Design Control, Design and Process Validations, Gauge R&R, Test Method validations, pilot manufacturing for clinical builds, design transfer for commercial manufacturing
  • Experience optimizing processes, developing, and implementing test procedures, forming process parameters, test methods and standard operating procedures, capacity, and profitability for medical device manufacturing
  • Possess a mindset for working in a regulated business industry following defined processes and procedures
  • Work closely with mentor and colleagues, give and receive constructive criticism and display questioning attitude
  • Highly organized and task-focused
  • Motivated to self-learn and develop
  • Effective communications skills, written and oral

3. BS in Industrial Design with 3 Years of Experience

  • Experience in software projects that follow (IEEE, SO, CMMI, ASME, NQA-1) software engineering standards (requirements, design, implementation, testing)
  • Working understanding of data modeling approaches
  • Working understanding of software test approaches
  • Understanding of end users’ expectations of software
  • Experience with modern programming languages: Fortran 95/2003, Java, C/C++, C#/.NET
  • Experience with source code control systems
  • Experience with Microsoft Office applications: Outlook, Word, Excel, PowerPoint, Access
  • Proficiency in English language, critical for reading and writing technical documents
  • Ability to work effectively in an international team-oriented environment
  • Possess a mindset for finding, analyzing and efficiently solving variety of software related problems

4. BS in Computer Science with 6 Years of Experience

  • Subject matter expertise in Medical Device Development
  • Development of reinforced shafts and sheaths, including steerable catheters
  • Proficiency in solid 3-D modeling (i.e. SolidWorks)
  • Strong knowledge of mechanical design
  • Able to communicate in English
  • Able to use Solid-Work and AutoCAD
  • Good knowledge of quality systems such as ISO9001:2015
  • Must be a team player
  • Subject matter expertise in a directly applicable sub-field (e.g. medical device development, mechanical assembly, catheter systems, electro-mechanical, steerable catheters, etc.) 
  • Proficiency in solid 3-D modeling (i.e. SolidWorks)

5. BS in Aerospace Engineering with 2 Years of Experience

  • Experience in pump design and/or development
  • Ability to produce and interpret pump detail design drawings from conceptual and iterative ideas
  • Ability to manage multiple projects simultaneously
  • Must be a flexible, inquisitive and multi-talented “out of the box thinker” who is eager and willing to take on new challenges and share ideas and knowledge.
  • Strong organizational skills
  • Ability to develop and maintain cost data
  • Ability to analyze product design needs from VOC and convert them to preliminary product design and cost estimates. 
  • Strong collaboration skills cross-functionally
  • Experience working through all aspects of medical device design & development including design verification and validation, process validation, and technology transfer 
  • Ability to perform statistical analysis using k-factors, Ppk, and DOEs along with root cause analysis

6. BS in Systems Engineering with 5 Years of Experience

  • Strong understanding of optical, electrical, and thermal properties of passive and active devices and materials
  • Experience with photonic simulation tools (e.g., mode solvers, FDTD, beam propagation) and electronic-photonic design and layout tools is desirable
  • Experience with the design and layout of electronic-photonic integrated circuits for fabrication in commercial and/or government foundries is desirable
  • Knowledge of electronic-photonic fabrication processes (e.g., lithography, deposition, etching)
  • Knowledge of chemistry, electrical and optical characterization techniques, and advanced packaging techniques is desirable
  • Excellent documentation and communication skills, and be able to work both independently and in a dynamic multi-discipline team environment
  • Experience in the medical device field
  • Ability to lead a team toward operational objectives with aptitude to contribute to strategic goal-setting for department/business unit 
  • Must be able to function with little or no supervision 

7. BS in Biomedical Engineering with 4 Years of Experience

  • Experience with catheters in the medical device field 
  • Experience working through aspects of medical device design & development including design verification and validation 
  • Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility, Design Verification) using a risk-based approach (dFMEA)
  • Must have demonstrated leadership qualities.
  • Must have excellent oral, written communication skills.
  • Ability to work under pressure with a minimum of supervision.
  • Great organization and planning skills
  • The ability to perform statistical analysis