Engineer - Degreed III_SJM in Plano, TX at Volt

Date Posted: 9/18/2020

Job Snapshot

Job Description

Continuous Improvement Engineer (4-month contract)
Plano, TX

Volt has partnered with a growing manufacturing company in search of a Continuous Improvement Engineer!

Responsibilities:

• Review, revise/release as needed Risk Documents for impacted line items – DFMECA and PFMECA.
• Review PRDs and identify those impacted and provide solid rationale for those not impacted.
• Review mechanical verification reports and identify tests impacted by the projects.
• Review, revise/release as needed tolerance analysis between electrode and cannulas.
• Review, revise/release as needed drawings - Disposable Electrodes, Cannulas, and Fixtures.
• Assess test methods – develop Q1 2021 plan for TMV as needed and secure coordination with Test Lab.
• Assess test fixtures – develop Q1 2021 plan for technical review as needed.
• Develop mechanical characterization 2021 plan (protocol/execution/report) – analytical and/or physical test and secure coordination with Test Lab.
• Develop mechanical test verification 2021 plan (protocol/execution/report) and secure coordination with Test Lab.
• Coordinate with PM’s foreach project and account for R&D time in overall plan to review and approve FAI, Qualification, Inspection, Testing, and Manufacturing Procedures documentation.
• Provide regular status updates to Mechanical RFA SME.

Requirements:

• Mechanical Engineer with 5+ years serial production class II or III medical device experience.
• Proven continuous improvement project track record.
• Extensive experience with testing medical devices and supplier/production qualification (FAI, IQ, OQ, PQ, PPQ).
• Able to provide clear and concise weekly updates easily demonstrating project status.
• Deep knowledge of medical device design controls.
• Demonstrated knowledge of risk management techniques.
• Highly developed leadership skills/experience including ability to map task interdependencies, prioritize such tasks, meet deadlines and develop, monitor and live within budgets.
• Ability to forecast major milestones.
• Knowledge of statistical techniques for capability analysis and performing tolerance analysis.
 

Volt is an Equal Opportunity Employer