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Principal Quality Engineer NPD (Irvine or Santa Rosa)

Company: Endologix, Inc.
Location: Irvine
Posted on: September 12, 2020

Job Description:

OVERVIEW

Principal Design Assurance Engineer (DAE) demonstrates advanced knowledge of quality engineering policies, principles and best practices used in development of new products and processes. This individual will be expected to apply his/her knowledge of industry regulations, including FDA (21 CFR 820),ISO 13485 and ISO14971, and design control and assurance principles to positively influence development efforts. Responsible and accountable for DAE deliverables required within the product development process, inclusive of but not limited to risk management, design requirement, test method development and strategy, statistical analysis and verification and validation.

RESPONSIBILITIES

* Integral member of product development team responsible for supporting activities required to ensure quality of the design through compliance with design controls.

* Work closely with product development engineering, clinical, marketing and regulatory to assure appropriate requirements are defined for the specific device application and target patient population.

* Collaborates with product development and promotes clinically relevant test methodologies required to complete analysis of device designs. Contributes to test method validation activities. Develops Design Verification/Validation test protocols, execution, and reports as required. Leads aging testing protocol development, execution, and reports as required

* Directs product risk management activities including leading Design and Use Failure Mode and Effect Analysis (FMEA) and essential requirements analysis. Supports and participates in development of process risk management efforts.

* Works with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability. Provides guidance for development of manufacturing test/evaluation methods and process validations.

* Represents Quality function in Design and Phase reviews, ensuring that key project activities are completed for each product development phase. Report on functional group progress and escalate project issues to management level, as warranted.

* Ensures DHF completeness, as appropriate or required. Supports audits and compliance assessments of the Design History File (DHF) and other program files to ensure quality requirements are met and audit findings appropriately addressed.

* Supports Post Market Surveillance activities, including serving as a technical resource for problem investigations to guide root cause analysis and corrective action development.

* Act as mentor to less experienced team members and Design Assurance Engineers.

QUALIFICATIONS

Education:

* Bachelor s degree in engineering or science discipline 12+ years of experience

* Master s degree in engineering or science discipline 8+ years of experience

* PhD in engineering or science discipline 5+ years of experience

Experience:

* Minimum of 12 years of experience with a Bachelor s degree; or 8 years and a Master s degree; or a PhD with 5 years of experience; or equivalent combination of education and experience in medical devices preferably implantable medical devices

* Exposure to or experience working in or with Design, Quality, and Operations

* Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity

* Knowledge of project management tools and techniques including activity, schedule, budget, and resource planning

* Strong COLLABORATION and INFLUENCE skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others needs, negotiate for win-win, own the whole, technical leadership)

* Strong written and oral COMMUNICATION skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)

* Drive the identification and proper collection of performance objectives, design requirements, measures and metrics. Implement to meet these criteria in collaboration with Design Engineering, Operations Engineering, Regulatory Affairs, and other cross-functional partners.

* Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation

* Background in comprehensive product design and development (requirements analysis, concept development, subsystem and component design, systems integration, verification/validation, and operations and product support)

* Strong statistics background (sample size calculation, comparison of group performance, reliability evaluation, and

* Mastered regulatory compliance awareness, including at a minimum FDA design controls CFR 820, ISO 14971, ISO 13485.

* Experience in test method development and assessment and establishing relevant test parameters

* Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)



Desired/Preferred Qualifications

* Minitab statistical software

* CQE Certification

* Design for Lean Sigma (DFLS) / Six Sigma / Design for Reliability and Manufacturing (DRM) experience

* Working knowledge of FEA simulation tools and analysis

* Experience with euMDR requirements strongly preferred



Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: Endologix, Inc., Irvine , Principal Quality Engineer NPD (Irvine or Santa Rosa), Engineering , Irvine, California

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