Senior Manufacturing Engineer

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Manufacturing Engineer position is a unique career opportunity that could be your next step towards an exciting future.

Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

The Senior Manufacturing Engineer applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

How you'll make an impact:

• Support process optimization initiative for delivery systems release testing, including design and implementation of in-process monitoring controls using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards

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

• Resolve complex manufacturing and compliance issues related to process changes, RA submissions, and regulatory requirements

• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes

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

What you'll need (Required):

• Bachelor's degree in an Engineering or Scientific field plus at least 4 years of Industry experience

• Certifications in Six Sigma or Lean Black belt preferrable
  

What else we look for (Preferred):

• Proven expertise in usage of MS Office Suite including MS Project

• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

• Strong understanding of statistical techniques

• Demonstrated application of DMAIC methodology in process improvement projects

• 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

• Expertise in process validation, equipment qualification, and lean manufacturing

• 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 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