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Staff Engineer (R&D, NPD)

Ultimate Irvine, CA Contractor
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A large, global medical device company in Irvine has an opportunity for an R&D Engineer

Job Duties:

•         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%)

•         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%)

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

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

•         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%)

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

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

•         Top Skills:

o    Electro-mechanical integration and electronics exposure

o    Knowledge of design and manufacturing of electro-mechanical medical devices

o    Solid understanding of general manufacturing processes including machining and injection molding

o    CAD Solidworks experience with understanding of ASME Y14.5 standards

o    Electronic Packaging experience

o    Plastic Part Design experience

•         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 the company's 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:

•         Associate Degree and 6- 8 years' experience required - med device experience is a plus Or

•         Bachelor's Degree and 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 preferred 



We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Recommended skills

Complex Problem Solving
Critical Thinking
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Job ID: JO-2001-82571


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