- Apply knowledge of quality engineering principles to ensure compliance with regulatory requirements.
- Focus on Design Control, Design Verification, Design Validation, Specification Development, and Test methods.
- Develop update, and maintain technical content of risk management files. Perform Failure Mode and Effects Analysis to identify product risks.
- Apply statistical knowledge in developing Statistical Reliability tests and statistical sampling plans.
- Critical review and approval of design specifications and design changes; partner with R&D in the design of safe and effective CC devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of CC devices
- Identify and optimize complex manufacturing processes using engineering methods such as 6 Sigma and LEAN for design for manufacturing and for continuous process improvement.
- Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products
- Evaluate failed devices, alternate components, materials and suppliers and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
Required Education & Skills:
- Bachelor's Degree in Engineering (Electrical ‘preferred’, Biomedical, or Mechanical) + minimum of 4 years of industry experience OR Master's Degree in Engineering + minimum of 3 years of industry experience
- Strong understanding of FDA medical device regulations. Design Control knowledge is a plus
- Must be able to work in a team environment, including inter-departmental teams. Ability to interact professionally with different functional groups including R&D, Regulatory, Operations, and Clinical Affairs. Experience working with R&D to affect design for manufacturing, mistake-proofing and robust design transfer to manufacturing
- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Knowledge of Electronics, IEC-60601 standard, and systems engineering are a plus.
- Working knowledge and understanding of statistical techniques. Strong ability to identify, interpret, and apply statistical sampling methods.
- Ability to manage competing priorities in a fast paced environment
- Strong problem-solving, organizational, analytical and critical thinking skills
- Ability to identify and describe quality system documentation components, including quality policies and procedures
- CQE (Certified Quality Engineer) and 6 sigma Black Belt certification are a plus
- Knowledge in using Quality Control Tools such as flowcharts, Pareto Charts, Cause and Effect diagrams is a plus.
- Demonstrate troubleshooting skills and capability in evaluating process changes and/or nonconformances for risk management or for developing technical justifications.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.