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Careers at Hansen Medical

Product Assurance/Verification Engineer

Position Description:

This role is within the engineering group and involves supporting the design and process development engineers from a product assurance perspective. The role involves providing support to teams on validation and verification planning and execution, test method development and validation, process optimization and validation

Position Responsibilities:

• Ensure product development teams follow design control requirements.
• Define Design Verification requirements, preparation and approval of DV protocols and reports.
• Work with new product development teams to develop inspection criteria and sampling plans and guide teams on regulatory requirements, statistical techniques etc.
• Lead failure investigation and corrective actions during development process.
• Work with quality and regulatory to lay out requirements for design changes post launch
• Implement and validate gauging and fixturing necessary for inspection and testing at component and finished product level. (Gage R&R studies)
• Ensure Design review packages are thorough and give guidance to teams on carrying out and documenting design reviews.
• Make recommendations and drive changes/continuous improvement to Design Control SOPs
• Help with compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements)
• Work with process development engineers and give guidance on laying out Designs of Experiments, choosing appropriate designs and helping to determine transfer functions between inputs and outputs for all critical processes.
• Define process validation requirements, preparation and approval of Master Validation Plans, protocols and reports. (IQs, OQs and PQs)
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, Cpk analysis, sampling techniques)
• Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
• Creation and maintenance of the DHF for all products

Basic Qualifications:

• Bachelors Degree in engineering or science field
• Minimum 7 years of practical experience in medical product Quality Assurance.
• Excellent knowledge of FDA and ISO 13485, FMEA, Hazard Analysis and Good Design Practices.
• Knowledge of GMP regulated environment required
• Strong project management skills.
• Strong technical and analytical expertise to assist in problem solving.
• Knowledge of statistics and their application required (Minitab or equivalent)
• Knowledgeable on setting up single and double sampling plans for attribute data
• Trained in DFSS techniques preferred, especially Gage R&Rs, DOEs, data analysis.

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