Provides expertise in the optimization of manufacturing processes.
**How you'll make an impact**:
- Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
- Lead in the identification 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
- Train, coach, and guide lower level employees on more complex procedures
- Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work
- Lead and establish complex project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
- 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
- Other incidental duties
**What you'll need (required)**:
- Bachelor's Degree in Engineering or Scientific field with minimum of 6 years of experience, including either industry or industry/education, required; or
- Master's Degree or equivalent in Engineering or Scientific field with minimum of 5 years of experience, including either industry or industry/education, required; or
- Ph.D. or equivalent in Engineering or Scientific field with minimum of 2 years of experience, including either industry or industry/education, required.
- Experience in transfers, equipment and process validations, required.
- Experience with Solution Mixing, preferred.
- Fully Bilingual (English/Spanish)
**What else we look for**:
- Proven expertise in usage of MS Office Suite; CAD experience preferred
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
- Ability to translate technical information to all levels of the organizations
- Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
- Advanced problem-solving, organizational, analytical and critical thinking skills
- Extensive understanding of processes and equipment used in assigned work
- Strong leadership skills and ability to influence change
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
- Represents organization in providing solutions to difficult technical issues associated with specific projects
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control