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The Opportunity

We currently have an opening for a Product Performance Engineer for the Vascular division. This role can be located at our Temecula, CA location. This is a fully onsite role.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

What you’ll do:

Identify, analyze, investigate, monitor and document patterns and trends in post marketing surveillance data as part of the CAPA system. Analyze and investigate product complaints from the field as part of post market surveillance requirements. Communicate and educate management, R&D, marketing, sales organization and other departments, as well as external customers about product performance. Ensure that information and insight gained from the investigations and corrective actions is fed back to the R&D and marketing organizations as part of the risk management and design input systems. Develop Post Market Surveillance Plans and provide engineering support for complaint investigation readiness of new products.

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Analyzes customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary.
• Investigates customer complaints related to product quality or patient safety.
• Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams.
• Documents trend action by updating the trend report at appropriate levels and by performing a Health Risk Analysis.
• Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
• Develop test plans, procedures, justifications papers and provide engineering support for new product complaint readiness.

(Supervision Received) Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

(Supervision Provided)

May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

Position Accountability / Scope

(Influence/Leadership)

Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower-level individual contributors. Influence exerted at peer level and occasionally at first levels of management.

(Planning/Organization)

Plans, organizes, and prioritizes own daily work routine to meet established schedule.

(Decision Making/Impact)

Exercises authority and judgment within defined limits to determine

appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

(Technical/Business Knowledge (Job Skills))

Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job

in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

(Cognitive Skills)

Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

EDUCATION AND EXPERIENCE YOU’LL BRING:

• Minimum Education Bachelor's degree
• 2-5+ years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2+ years of related work experience, or an equivalent combination of education and work experience.

Minimum Experience / Training Required

• Medical Devices experience is preferred.
• CAPA experience a plus
• CQE/ASQ a plus
• Medical writing a plus
• Statistical analysis a plus
• Six sigma background a plus