Sr. Engineer (Manufacturing/Validation)
Company: Ultimate
Location: Irvine
Posted on: January 14, 2021
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Job Description:
Key responsibilities:* Coordinates tooling / process capability
studies as required.* Provides technical input for strategic
sourcing projects, including evaluation of supplier capability,
part qualification plan, specification review, product
implementation and part transition to manufacturing.* Participate
in technical discussions with suppliers to identify and implement
improvements in products and processes.* Responsible for defining
supplier qualification requirements for OEM, Contract manufacturer
(components and devices) and custom materials, including supplier
validations and company receiving inspection fixture design for
Test method validation. * Respond with a high sense of urgency to
quality issues and escalate / communicate appropriately.* Ensure
that Tier 1 suppliers are using capable Tier 2 suppliers for
material and outside processing services.* Work with supplier to
optimize processes.* Perform other duties and responsibilities as
assigned.Skills:* 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/controlEducation & Experience:* Bachelor's Degree in
Engineering or Scientific field with 4 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.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.SDL2017
Keywords: Ultimate, Irvine , Sr. Engineer (Manufacturing/Validation), Other , Irvine, California
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