Overview
Skills
Job Details
"Investigate 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.
Identify and ensure the optimization of complex Manufacturing and/or R&D 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, update, and maintain technical content of risk management files
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.
Train, coach, and guide lower level employees on routine procedures"
Knowledge
" 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
- Good leadership skills and ability to influence change"
Problem Solving / Job Complexity
" Develops solutions to a variety of complex problems
- Identifies opportunities for process improvements"
Discretion / Latitude and Supervision
" Work is performed independently and reviewed upon completion for adequacy in meeting key objectives
- Participates in determining objectives of assignment; plans schedules and arranges own activities in accomplishing objectives
- Acts as a resource for colleagues with less experience"
Impact
" Contributes to the completion of significant organizational projects and goals; Input on overall objectives and long-range goals of the organization is given serious consideration
- Failure to conclude their piece of a project would have impact causing schedule delay and/or addition of resources"
Liaison
" 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"
Typical Education / Experience
" Bachelor's Degree in Engineering or related field with 4 years related industry experience Required or Master's Degree or equivalent in Engineering or related field with 3 years related industry or industry/education experience Required or
- Ph.D. or equivalent in Engineering or related field with 0 years experience Required
- Other: CQE (Certified Quality Engineer), if applicable Preferred
- Proven expertise in usage of MS Office Suite; CAD experience preferred
- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Working knowledge and understanding of statistical techniques
- Previous experience working with lab/industrial equipment required
- 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
- Good leadership skills and ability to influence change
- 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 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"