DFM Sr Process Engineer

Key Responsibilities

• Leads and/or is part of and/or provides support to:

• Evaluates risks, quantifies/estimates impact, and sets expectations for global corporate teams.
• Has the ability to manage engineering resources to define, monitor, and complete activities according to the needs of the organization or project.
• Directs, guides, and develops requirements for global corporate teams to ensure business goals are met.
• Conducts root cause analysis through observation and analysis of physical and chemical phenomena intrinsic to the process to theorize, test, and quantitatively measure their effects.
• Designs experiments and test methods to evaluate the feasibility of a change point in the production environment.
• Designs scalable processes focused on productivity and quality, minimizing dependence on manual processes prone to failure.
• Effectively and quantitatively communicates and provides feedback on any development element intended to be incorporated into the production environment.
• Evaluates advanced 3D printing technology, CNC, as well as complex hardware and software subsystems integrated into the raw material transformation process.
• Establishes operational ranges and process limits using statistical control methodologies to ensure process stability and scalability, as well as product conformity within established ranges.
• Validates and documents change points in compliance with ISO 13485 prior to their implementation in the production environment.
• Interacts with local manufacturing teams
• Establishing and monitoring "Key Performance Indicators (KPIs)" during the early stages of implementing a change point.
• Providing support and making design adjustments during the early stages of implementing change points.
• Providing support for conducting investigations and root cause analysis of internal problems and/or customer complaints reported in the field.
• Providing consultancy and guidance on local Engineering projects to ensure proper risk assessment, integration, and interaction with the process.
• Use project management methodologies (Preferably AGILE/SCRUM) to:
  o Determine scope
  o Generate financial impact modeling
  o Identify and break down the timeline of activities
  o Ensure necessary resources
  o Ensure compliance with activities

Skills, Knowledge & Expertise

• Completed professional degree in the following Engineering fields:

• Minimum of 5 years of experience in a similar position
• Postgraduate studies or specialization in Manufacturing, Design, Mechanical, Additive Manufacturing, Productivity, Quality Systems, Automation, Product Design
• Experience in the medical or pharmaceutical industry regulated by the FDA
• Previous work experience in roles related to Manufacturing Process Design, New Product Introduction to the Manufacturing Process, and Product Launch
• Experience in the Automotive industry
• Six Sigma certifications; Master Black Belt, Black Belt, Green Belt
• Knowledge in the following areas:
  o ISO 13485:2003
  o JPAL (Japan Ministry of Health, Labor, and Welfare - Ordinance No. 169, 2004)
  o SOR/98-282 (Canadian Medical Device Regulation)
  o MDD 93/42/EEC (European Council Directive)
  o U.S. Code of Federal Regulations
• Finite element analysis such as ANSYS, Abaqus, COMSOL, Matlab
• GD&T
• Programming in an object-oriented language such as C++, Python, C#
• SQL, Big Data, Machine Learning, AI
• Statistical Analysis with Minitab
• Solidworks or equivalent
• MS Office Suite
• Expert level in MS Excel
• Innovative and system integrity-oriented thinking with attention to detail
• High level of critical and methodical reasoning aimed at problem-solving
• Outstanding skills in system failure analysis
• Outstanding skills in conceptualizing ideas and hypotheses involving the interaction of physical phenomena
• May supervise others
• Intermediate - Advanced English