How You'll Make an Impact:
+ Investigate complex manufacturing product quality and compliance issues (e.g., Material Review Board, 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.
+ Develop and implement 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.
+ Implement and monitor Critical Control Points.
+ Develop, update, and maintain technical content of risk management files (e.g. FMEAs, Quality Control Plans).
+ Develop, optimize and validate high complexity test methods and associated equipment.
+ Collaborate with engineers for equipment selection and validation.
+ Develop training and documentation materials for production and Receiving Inspection (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
+ Implement and approve compliant change control.
+ 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'll Need (Required):
+ Bachelor’s degree in Engineering or a related field with 4+ years of relevant industry experience, or Master’s degree (or equivalent) in Engineering or a related field with 3+ years of relevant industry and/or academic experience.
What Else We Look For (Preferred):
+ Machining experience preferred
+ Optical inspection development experience 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.