Principal Released Product Engineer (R&D), CAPA

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Brooksource

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Pr. Released Product Engineer (R&D), CAPA

Irvine, CA – Hybrid

In this exciting role as a Pr. Released Product Engineer (R&D), CAPA, you will have responsibility for R&D technical leadership on CAPA’s and organizational improvement activities. You will coach and may lead teams through complex technical issues or testing failures to ensure quality and speed of resolution. This role will be a technical leader and provide mentorship of other R&D engineers working in the released product engineering group and must be capable of working in a highly collaborative, fast-paced environment.

Neuroscience Portfolio

The Neuroscience Portfolio develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.Neurovascular Business Unit offers an integrated portfolio of devices and therapies for the treatment of stroke related diseases.

Responsibilities:

  • Own Corrective and Preventative (CAPA) activities or other remediation activities from issue identification through implementation of corrective/preventative action and effectiveness monitoring, including a detailed root cause investigation and analysis.
  • Identify and resolve complex technical problems
  • Works cross-functionally on multiple teams to make decisions and deliver results
  • Provide technical leadership and engineering support to cross-functional teams as a subject matter expert.
  • Coaches, reviews and delegates work to lower-level specialists including solving issues or engineering activities
  • Partner with Program Managers and other cross functional leaders to build relationships and influence teams and decisions.
  • Understands the Neurovascular Business objectives and strategy and can apply them to project work prioritization, strategy and decision making.
  • May approve or author DMR and DHF documents (Protocols, Reports, Plans, Manufacturing Instructions, drawings, product specifications, etc.)
  • Establish and improve manufacturing processes, quality systems, and business processes.

Minimum Requirements:

  • Medical device experience
  • Statistical expertise
  • CAPA experience
  • Endovascular (especially Neurovascular) knowledge and experience
  • Lean six sigma methodology / DFSS / DRM / DMAIC training or other root cause investigation expertise
  • Project management experience
  • Strong communication and influence skills
  • Ability to manage several projects or deliverables concurrently and manage prioritization.
  • Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.
  • R&D Engineering experience and strong knowledge of product development process, test method development and validation, design verification/validation, process validation and developing design requirements.

Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

JO-2212-131203

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