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Scientific. Clinical. Software Engineering

Sr Engineer

Orange County Metro Area, CA

Job Type: Engineering Job Number: JN -042020-26768 Region: Orange County Metro Area

Job Description

Sr Engineer

Lifesciences Industry

Irvine, CA


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

Job Functions

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

Develop 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 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

Lead and 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


Root Cause Analysis

Strong Documentation


Knowledge of SPC and six sigma

Test Methods development and Validation


Electronic/Software experience

FDA/ Regulated environment

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

Basic understanding of statistical techniques

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 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

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


Bachelor's Degree in Engineering or Scientific or 4-6 years experience including either industry or industry/education OR Master's Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education OR Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education.

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