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Staff Engineer

Orange County Metro Area, CA

Posted: 09/13/2019 Job Type: Engineering Job Number: JN -092019-25610

Staff Engineer

Lifesciences Industry

Irvine, CA


1. Lead in the identification 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 (20%)

2. Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on a simple product line(s) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports (20%)

3. Train, coach, and guide lower level employees on more complex procedures (20%)

4. Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work (15%)

5. Lead and establish complex project plans to ensure deliverables are completed to customer s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) (10%)

6. Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations, black belt thought map) (5%)

7. Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes (5%)


Skills: Additional Skills:


Proven expertise in usage of MS Office Suite

Ability to read and interpret drawings

Proven expertise in statistical techniques

Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills

Ability to translate technical information to all levels of the organizations

Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)

Knowledge of Six Sigma concepts with ability to apply to work product

Knowledge of Quality Engineering concepts with ability to apply to work product

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

Extensive understanding of processes and equipment used in assigned work

Strong leadership skills and ability to influence change

Knowledge of and adherence to our Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Work is performed independently while exercising considerable latitude in making significant decisions

Set policies and standards that are followed by others

Guides others in resolving basic issues in specialized area based on existing solutions and procedures

Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts

Represents organization in providing solutions to difficult technical issues associated with specific projects

Develops technical solutions to complex problems which require the regular use of creativity

Uses best practices and knowledge of internal or external business issues to improve products/services or processes

Typically resolves complex problems or problems where precedent may not exist


Education and Experience:


Bachelor's Degree or equivalent

6 years experience including either industry or industry/education Required Or Master's Degree or equivalent

5 years experience including either industry or industry/education Required Or Ph.D. or equivalent in in Engineering or Scientific field

2 years experience including either industry or industry/education Required

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