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Senior Engineer, Quality
hace 3 semanas
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
We recently announced plans to expand in Spain by building a new, state-of-the-art manufacturing plant in Moncada, Valencia. When it becomes operational in 2026, the plant will manufacture Edwards' surgical and transcatheter heart valve replacement technologies and will join a global network of more than 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 dedicated team members by 2029 across manufacturing, engineering, and several other professional career paths. Hiring for professional positions has started and will continue through the winter and early spring, with specialized training for manufacturing hires beginning in the fall of 2025.
**How you will make an Impact**:
- Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
- Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
- Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
- Develop, update, and maintain technical content of risk management files
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- Train, coach, and guide lower level employees on routine procedures
- Other incidental duties assigned by Leadership
**What you will need (required)**:
- Bachelor's Degree in Engineering or related field, 4 years experience in related industry experience or
- Master's Degree or equivalent in Engineering or related field, 3 years experience in related industry or industry or
- Ph.D. or equivalent in in Engineering
**What else we look for (preferred)**:
- Proven expertise in usage of MS Office Suite; CAD experience preferred
- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Working knowledge and understanding of statistical techniques
- Previous experience working with lab/industrial equipment required
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Strong problem-solving, organizational, analytical and critical thinking skills
- Substantial understanding of processes and equipment used in assigned work
- Good leadership skills and ability to influence change
- Knowledge of and adherence to Quality systems
- 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 inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
- 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
