Product Development Engineer - Louisville

Role Summary

Contribute to the development of medical devices from concept through production by applying strong technical judgment, customer-centric design principles, and sound engineering practices. Work on simple to moderately complex design and project tasks with general oversight, receiving close supervision only on unusual or difficult problems.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
• Understanding of medical device product development processes and lifecycle, including concept, design, verification, validation, and manufacturing transfer.
• Working knowledge of:
  • Design for Manufacturability (DFM).
  • Geometric Dimensioning and Tolerancing (GD&T).
  • Tolerance stack-up analysis.
• Familiarity with manufacturing processes such as:
  • Machining
  • Injection molding
  • Common joining methods
  • Rapid prototyping
• Working understanding of risk management principles and tools as applied to medical devices across the product lifecycle.
• Awareness of or exposure to Design for Six Sigma (DFSS) concepts, statistical methods, and design of experiments (DOE).

• Competent in 3D CAD, preferably Solid Works.
• Familiarity with statistical software (e.g., Minitab) for data analysis and DOE.

• Ability to independently perform simple to moderately complex design tasks and project activities.
• Capable of conducting research and technical investigations to support design decisions.
• Able to formulate and solve engineering problems that require a moderate level of technical knowledge.
• Ability to evaluate, select, and apply standard engineering techniques, procedures, and criteria to perform tasks or sequences of tasks on projects with moderately complex features.
• Strong technical writing skills, with the ability to author engineering reports, protocols, and verification/validation documentation with moderate guidance.

• Demonstrated problem-solving skills, with a drive to identify root causes and develop practical solutions.
• Ability to apply DFSS tools and statistical methods (including DOE) to support product and process optimization.
• Capable of analyzing tolerance stack-ups and assessing design impacts on manufacturability and performance.

• Ability to interact effectively with project teams, suppliers, customers, contractors, and other stakeholders.
• Supports builds and manufacturing transfer activities, working cross-functionally with operations, manufacturing, and quality.
• Able to prepare and maintain project documentation in a timely and accurate manner.

• Fast and accurate communication with team members and management.
• Able to explain technical concepts clearly to both technical and non-technical stakeholders.

• Action-oriented and detail-focused
  :
  Takes initiative, follows through on tasks, and maintains high attention to detail.
• Continuous learner
  :
  Demonstrates an aptitude for technical learning, progressing from limited knowledge in some areas to broader competence across multiple practice areas.
• Quality and customer focus
  :
  Designs with end-user needs and quality requirements in mind, applying risk management tools to identify, assess, and mitigate risks.
• Collaborative
  :
  Works constructively within cross-functional teams and with external partners (suppliers, contractors, customers).
• Results-driven
  :
  Shows a strong drive for results and completion of tasks to a high standard.
• Adaptable
  :
  Willing and able to work flexible hours and adjust to changing project needs and priorities.

• Bachelor’s Degree; approximately 2 years of work experience in health and/or business-related environments
  OR
• Master’s Degree; 0–2 years of work experience in health and/or business-related environments.

Relevant experience should include some combination of:

• Participation in medical device or related product development projects (from concept to verification/validation and/or manufacturing transfer).
• Hands-on involvement with engineering builds, prototyping, and/or manufacturing process support.
• Preparation of engineering documentation (reports, test protocols, test reports, risk…