Edwards Lifesciences is looking for a Senior Engineer Quality to help optimize product development and ensure the highest standards of integrity and safety in their groundbreaking structural heart technologies.
Requirements
- engineering methods (e.g., SIX Sigma and LEAN methods)
- technical design skills
- writing and executing protocols
- CAPA
- non-conformances
- audit observations
- project management tools (e.g., Project Plan, Risk Analysis, etc.)
Responsibilities
- Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards
- Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
- Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
- Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
- Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
Other
- Bachelor’s degree in Engineering or a Scientific field with 4 years of relevant experience, or a Master’s degree with 3 years of relevant experience in industry or a combination of industry and education.
- Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Good leadership skills and ability to influence change
- Knowledge of applicable FDA regulations for medical device industry
