Principal Engineer, NPD-Quality

In this role, you'll apply quality engineering expertise to enable innovation while ensuring compliance with regulatory requirements and Edwards' quality systems.

How you will make an impact:

• Provide leadership and oversight for a device, system, or project to 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
• Lead identification, development, and optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to improve manufacturing processes and/or test methods, and reduce overall process/product risk profile.
• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust processes and/or test methods based on engineering principles; ensure completion of comprehensive usability studies, design verification and validation, validations for process and test methods, including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion
• Lead in the investigation of complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development and based on engineering principles; analyze results, make recommendations and develop reports. Act as subject matter expert for internal and/or external audits for products and/or processes. Support regulatory submissions and addressing responses during regulatory reviews.
• Train, coach, and guide lower-level employees on more complex procedures. Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
• Other incidental duties

What you'll need (Required Qualifications):

• Bachelor's Degree in Engineering or Scientific field, 6 years' experience, including either industry or industry/education or
• Master's Degree or equivalent in Engineering or Scientific field, 5 years' experience, including either industry or industry/education or
• Ph.D. or equivalent in Engineering or Scientific field, 2 years' experience, including either industry or industry/education

What else we look for (Preferred Qualifications):

• American Society for Quality Certification (ASQ) ASQ Certified Quality Engineer (CQE)
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Ability to translate technical information to all levels of the organizations
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Strong leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• 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 frequent inter-organizational and outside customer contacts
• Represents organization in providing solutions to difficult technical issues associated with specific projects
• 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