Engineer II, New Product Development Quality, TMTT

Imagine how your ideas and expertise can change a patients life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering this role you will apply your 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.

How you will make an impact:
Develop and validate complex test methods (including writing and executing protocols) to create validate and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results make recommendations and develop reports.
Develop update and maintain technical content of risk management files
Work closely with R&D and Clinical Development to collaborate on project deliverables and meeting timelines.
Engage on design assurance and reliability related activities.
Investigate moderately 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.
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 reduce risk
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.
Other incidental duties assigned by Leadership

What youll need (Required):
Bachelors Degree in Engineering or Scientific field 2 years experience related work experience OR
Masters Degree or equivalent in and internship senior projects or thesis in Engineering or Scientific field including either industry or industry/education
Experience with test method development and validation

What else we look for (Preferred):
Good documentation communication and interpersonal relationship skills including negotiating and relationship management skills
Experience with risk management documentations (i.e. RMW DFMEA)
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
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 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 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

Aligning our overall business objectives with performance we offer competitive salaries performance-based incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California the base pay range for this position is $85000 to $120000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.