Quality Engineer, Senior Staff

Salary Range:

$122,625.00 - $204,375.00...

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

We're looking for a Senior Design Quality Assurance Engineer to join our Fremont, CA team! As a uniquely qualified candidate, you will:
? Drive New Product Development quality engineering tasks and documents required for early design and project kick off. Taking customer concept drawings and discussions to project and quality deliverables. Able to support US and OUS regulatory submission documentation for customer. Apply early design excellence/assurance early in the design life cycle
? Develop, apply, revise and maintain quality standards for processing materials/product into partially or finished products
? Design and implement methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
? Analyze non-conformance reports and returned products and recommends corrective action
? Prepare documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, and inspection plans. Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence. Must be able to review and provide value-added feedback to others writing such documents
? Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Provides guidance to manufacturing and development engineers regarding documentation, process controls data feedback systems, and best quality practices
? Independently performs most assignments with instructions as to the general results expected
? Participate in design reviews and pre-validation assessments to ensure the safe environmentally sound start-up of new processes, and ensure the process has adequate and appropriate process controls. Responsible for participating and/or taking lead role in developing the risk management plan for new projects, including translation of product description requirements into hazard assessment, design trace matrix development, DV&V testing, and FMEA
? Practice company safety, quality policies and procedures, actively requires conformance
? Conduct new R&D supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset
? Respond to complaints from customers and investigating the root cause. Completing Medical Device Report (MDR) submissions

Education and Experience:
? BS or MS in a related engineering discipline with 5-10 years of related experience
? Prior experience in the medical device industry
? Knowledge of statistics and minitab is a must, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE) and response surface models, and variable and attribute sampling plan applications
? Experience in writing and review design verification and validation protocols would be an asset
? Experience in generating documentation and criteria for validation of manufacturing line transfer to alternative sites would be an asset
? Ability with standard and challenging processes/methods/equipment/tooling related to catheter manufacturing
? Able to troubleshoot moderately complex issues on existing processes/method/equipment/tooling
? Ability to read engineering drawings and understand inspection requirements.
? Good written and verbal communication skills
? Knowledge of good manufacturing principles (GMP)
? Attention to detail, professional attitude, team player

We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.

Confluent Medical Technologies is an equal opportunity employer

Apply Job!