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Scientific. Clinical. Software Engineering

Engineer II

Orange County Metro Area, CA

Job Type: Engineering Job Number: JN -072020-27137 Region: Orange County Metro Area

Job Description

Engineer II

Lifesciences Industry

Irvine, CA

Duties:


Applies knowledge of technical principles and our systems/procedures to optimize manufacturing processes.


Job Functions


Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills

Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports

Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)

Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes

Establish project plans to ensure deliverables are completed to customer s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

Other incidental duties assigned by Leadership


Level of Independence


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


TOP SKILLS:


medical manufacturing exp is required

supplier quality background

auditing

knowledge of molding and tooling

____


Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

Basic understanding of statistical techniques

Previous experience working with lab/industrial equipment required (if applicable)

Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

Solid problem-solving, organizational, analytical and critical thinking skills

Solid understanding of processes and equipment used in assigned work

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 the ability to manage vendors and project stakeholders

Ability to build productive internal/external working relationships

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


Education:


Bachelor's Degree in Engineering or Scientific field with 2-4 Years of Experience

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