PD Quality Engineer Senior Staff

Job Description:

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical device industry's most trusted partner, and we accomplish this with an organization focused on safety, efficiency, and customer satisfaction.

We are looking for a PD Quality Engineer Senior Staff to join our team in Costa Rica. If you enjoy working in a fast-paced environment and making an impact on our life-saving work, this may be a good fit for you!  As a uniquely qualified candidate, you will:

SUMMARY: The PD (Process Development) Quality Engineer Senior Staff works on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors, knowledge of industry regulations and best practices, and critical thinking skills. Participate in decisions on scope of work, selection of materials/equipment/test methodology, definition of processing steps and inspections, and length of tasks. Participate in decisions to recommend design changes to customers when necessary. Participate in the definition and documentation of Product/Process Risk Management, Process Validation and Test Method Validation.

 ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Responsible as part of a cross-functional team for developing, applying, revising and maintaining quality and regulatory standards for designing and processing materials/products into partially or finished medical device products.   
• Implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.   
• Diagnose and resolve manufacturing and quality system issues.   
• Participate in performing design, optimization, validation and production readiness reviews, to ensure the safe and environmentally sound start-up of new processes.   
• Generate and maintain risk management files supporting product and process development, such as Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents.
• Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis, ANOVA.   
• Support Product/Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data.   
• Write Process Validation and Test Method Validation Protocols, analyze data and write and release validation reports.   
• Creates Test Methods for new processes, including protocols, reports and execution.
• Establishes manufacturing controls base on drawings or product specifications.
• Communicate with Customer as needed on Process Development Responsibilities, Quality Issues and/or Supplier Initiated Change Requests.   
• Support Hosting of External Customer and or Notified Body Audits as applicable.   
• Investigate and manage customer field complaints, SCAR’s and internal CAPA’s as needed.   
• Represent Quality Assurance for Non-Conformance Report dispositions, and participate in monthly Oversight Review Boards as needed.   
• Provide training on quality system procedures and industry regulations/best practices.
• Interface with customers and suppliers as needed for quality issues and project requirements.   
• Follows all safety and production standard operating procedures.   
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for product safety and compliance.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.

EDUCATION and/or EXPERIENCE:

• Bachelor degree in a related engineering discipline.
• Master degree is a plus.
• 6-8 years of related experience working in Quality in a medical device environment.
• 4 years or more of experience in Medical Device Product Development, 5 or more years of experience with FDA, ISO 13485 and EU MDR Design Control requirements.
• Advanced English level.
• Demonstrated knowledge of and practical application of ISO 14971 and IEC 62366 requirements.
• Strong statistical data analysis skills using Minitab.
• Competent in Microsoft Office applications.
• Passport and VISA up to date.

COMMENTS:  This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.