Sr. Supplier Development Engineer
Orange County Metro Area, CA
Sr. Supplier Development Engineer
Costa Mesa, CA
The Engineer for Manufacturing at Suppliers is a manufacturing/operations role supporting supplier excellence by deployment of technical supplier assessments, improvement plan development and execution.
Ensuring that risks are mitigated, partnerships are developed and driving key and strategic suppliers future state growth. This role provides oversight for operations (both delivery and quality) projects at the suppliers.
Will help in improving and developing processes. Project management is a key function of this role and includes formal project planning and tracking. In addition, this role is part of a cross-functional team that is responsible for supporting sourcing strategies including supplier recommendations.
Lic/Certification - Six Sigma Black Belt, Lean Manufacturing preferred
Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Understanding of statistical techniques
Understanding of Operational Excellence Principles and tools.
Understanding of various Manufacturing processes (Molding, Extrusion, Machining, Assembly)
Strong Med Device Quality Systems knowledge
Previous experience working with lab/industrial equipment required (if applicable)
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 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 EHS rules and requirements 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
Ability to Manage Projects and move teams forward in various environments.
Works independently without close supervision
Compares and evaluates possible courses of action after considering various possibilities
Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met
Considers the cause and effect of activities
Determines or effectively recommends course of action after considering potential risks of alternatives
May provide guidance to lower level personnel
Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment
Direction tends to be high level and focused on end results with means of accomplishment left to incumbent
40% of the time - Perform supplier technical maturing assessments (Operational Excellence Model based) on selected suppliers. Collaborate on the development and deployment of associated improvement plan.
30% of the time - Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including 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 at suppliers
20% of the time - Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) at suppliers
10% of the time - Lead and establish project plans at suppliers to ensure deliverables are completed to customer s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
Bachelor's Degree in Engineering or Scientific field with 5-10 years experience including either industry or industry/education OR Master's Degree or equivalent in Engineering or Scientific field
Certifications & Licenses:
Six Sigma Black Belt