Prototype Engineer II, Metals CoE

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical

innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

Our Advanced (Use the "Apply for this Job" box below). harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

The position is a Prototype Engineer, fabricating metal components for early-stage feasibility in the Metals Center of Excellence in Advanced Technology.

How you’ll make an impact:

• Operates automated Laser CNC machinery and related equipment to fabricate precision metal parts by performing the following duties

• Ensures high quality of parts by closely monitoring and adjusting operation of machine and/or tooling while regularly inspecting parts

• Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills

• Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports

• Analyze and resolve moderately 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

• Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

• Other incidental duties assigned by Leadership

What you’ll need (Required):

Bachelor's Degree in Engineering (Mechanical Engineering preferred) and 2 years’ experience OR
Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education required

What else we look for (Preferred):

• CAD experience required, good computer skills in usage of MS Office Suite including MS Project;

• 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

• 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 preferred

• 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…