How you will make an impact:
• Develop, update, and maintain design control documentation through product development processes. Support development of design requirement documentation.
• Develop, update, and maintain technical content of risk management and usability files
• Optimize to optimize moderately complex Manufacturing 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/or test methods, and reduce risk
• Collaborate with R&D, manufacturing, and other cross-functional stakeholders to support process and/or test method development, product builds, clinical programs, design transfer, and product launch. Participate in process validation testing.
• Investigate moderately complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyze results, make recommendations and develop reports.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership

What you'll need (Required):
• Bachelor's Degree in Engineering or Scientific field, 2 years' experience related work experience OR
• Master's Degree or equivalent in senior projects or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred):
• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• 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 the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• 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