Sr. Development Quality Engineer

Alameda, CAfull timeOn Site

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senior

$125k–$175k

H1B: no

Penumbrainc Sr. Development Quality Engineer at Penumbrainc leads supplier development initiatives to improve quality, scalability, and supply continuity. Provides technical leadership and supports supplier qualification and risk reduction.

Responsibilities

Lead in the development and qualification activities for new and existing products.*
Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of engineering work for projects with various scopes. *
Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements. *
Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment.
Develop and validate measurement methods.
Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control requirements per regulatory and industry standards
Support developmental projects in the area of quality engineering
Analyze reports and recommend corrective and preventive action to adverse results.
Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications.
Support activities during FDA inspections and notified body audits. *
Participate in the development of standard operating procedures. *
Develop and approve documentation for inspection/testing procedures. *

Qualification

Experience leading supplier developmentLean or Six Sigma training preferred

Required

BS or MS degree in Engineering or related technical discipline.
6+ years of experience in Supplier Engineering, Supplier Development, Manufacturing Engineering, Quality Engineering, Supplier Quality Engineering, Operations Engineering, or related technical functions.
Experience leading supplier development, process improvement, supplier value-adds or capability development initiatives.
Experience working directly with suppliers to resolve technical, quality, or manufacturing challenges.
Demonstrated experience partnering with Procurement, Engineering, Manufacturing, and Quality organizations.
Strong technical problem-solving and project leadership skills.
Ability to independently lead initiatives with broad cross-functional impact.
Strong communication and stakeholder management skills.

Preferred

Medical device or other regulated manufacturing experience.
Lean or Six Sigma training preferred.
Experience with supplier diversification efforts, second-source programs, or supplier transfer initiatives.
Experience leading supplier Kaizens and continuous improvement efforts.
Experience supporting supplier capability growth, scalability, and operational excellence initiatives.
Experience assessing manufacturing processes, process capability, and production readiness.
Experience with global suppliers and complex supply chains.
Working knowledge of statistical methods, process validation, risk management, and root cause analysis methodologies.