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Scientific. Clinical. Software Engineering

Sr. Supplier Development Engineer

Orange County Metro Area, CA

Job Type: Engineering Job Number: JN -112020-27585 Region: Orange County Metro Area

Job Description

Sr. Supplier Development Engineer

Lifesciences Industry

Costa Mesa, CA

Duties:


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


Required


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.


Skills:


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.)


Education:


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:


CAPA

Lic/Certification

Six Sigma Black Belt


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