Sr. Quality Engineer - Design

Overview

Draeger Medical Systems, Inc., Andover, MA seeks Sr. Quality Engineer – Design, develop, test, and evaluate integrated systems for managing industrial production processes, including quality control, material flow, and design transfer to manufacturing with production coordination. Communicate with management and user personnel to develop production and design standards, following design control requirements and internal procedures and standards. Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product to include performing design reviews and approving design control documentation in accordance with defined procedures and engineering specifications to ensure results demonstrate compliance to medical electrical equipment standards such as IEC 60601-1 and IEC 62304 to establish customer requirements and technical standards.

Responsibilities

• Coordinate and implement quality control objectives, activities, or procedures to resolve production problems, maximize product reliability, or minimize costs to include maintaining compliance and continuously improving the QMS regarding ISO 9001, ISO 13485, and CFR 21 and further regulatory requirements which apply to the facility.
• Support product risk management and security requirements by assessing risk management deliverables (including FMEAs and Benefit-Risk Analysis) and usability engineering deliverables (including use specification, usability evaluation plan, and usability evaluation report) to prepare for FDA (510(k), PMA), EU and other international submissions for higher risk classification medical devices.
• Support implementation of design changes, including estimating production costs, cost saving methods, and the effects of product design changes and new product introduction.
• Act as the authorized Quality Assurance approver of changes by reviewing necessary design documentation such as first article inspections, 2D drawings used for machining and assembling processes, and part specifications.
• Take responsibility for individual CAPA’s and provide input into CAPA’s as appropriate by evaluating precision and accuracy of production and testing equipment and engineering drawings to formulate corrective action plans and performing root cause analysis through tools such as Ishikawa (Fishbone) diagram and five-why analysis.
• Prepare non-conformance list and corrective actions and facilitate CAPA program for products, projects, or processes.
• Recommend and develop manufacturing methods, labor utilization standards, and cost analysis systems to promote efficient staff and facility utilization to include design control methods and manufacturing process efficiency, by leading production continuous improvement projects focusing on lean manufacturing techniques, 5S, Kanban, and Kaizen.
• Provide quality engineering expertise to support preparation of risk management deliverables (such as Use FMEA, Design FMEA, Process FMEA, and Fault Tree Analysis) in line with ISO 14971:2019 and use statistical techniques to calculate risk probabilities for product benefit risk analysis as well as for complaint investigations.
• Prepare Health Hazard Evaluations when necessary for field action decisions.
• Support test method validation and Gage R&R study for risk probability calculation and statical process control.
• Review technical publications, articles, and abstracts to stay abreast of technical developments in industry and the regulatory landscape to make sure medical devices designs are following state-of-the-art practices and standards like ISO 14971, IEC 62366, etc.
• Monitor and improve Quality Management reporting systems to meet US region and business unit requirements while maintaining consistency with global Draeger Medical systems and communicating this information to local and global management and supporting all third-party inspections and audits (NB, FDA, etc.).
• Work with cross-functional teams to ensure QA and RA objectives are understood and achieved by conducting gap assessment of various international regulations like EU MDR (2017/745) for medical devices to remediate DHF (Design History File) and STED (Summary of Technical Documentation) files to recertify devices in international regions outside USA.
• Ensure escalation of identified gaps are resolved in a timely manner for regulation compliance perspective.

Qualifications

• Requires Master’s (or foreign educ. equiv.) Degree in Mechanical Engineering, Biomedical Engineering or closely related engineering field and two (2) yrs. experience in Job Offered or related occupation. Alternatively, will accept Bachelor’s (or educ. equiv.) Degree Mechanical Engineering, Biomedical Engineering or closely related engineering field and five (5) yrs. post-degree experience.
• Experience must have included: Use of Risk Management Standard ISO 14971:2019 and Usability Engineering Standard IEC 62366:2015; Conducting products technical files gap assessment of various international regulations and EU MDR 2017/745) for medical devices to remediate STED (Summary of Technical Documentation) files in order to get the medical devices recertified and get market clearance to those international regions.
• Assessing User FMEA, Design FMEA and Process FMEA risk evaluation in line with ISO 14971:2019 and calculated medical risk of Class IIb and Class III implantable medical devices through statistical techniques including Test Method Validation, Gage R&R, Statistical Process Control calculations in Minitab and Fault Tree Analysis to determine benefit-risk ratio.
• Performing Design Reviews for Medical Electrical Equipment operated through a software to conform the device designed satisfy IEC 60601-1 and IEC 62304 requirements.
• Assessing risk management deliverables (FMEAs and Benefit-Risk Analysis) and Usability Engineering deliverables (Use Specification, Usability Evaluation Plan, and Usability Evaluation Report) to prepare a package for 510(k) submission for Class II devices and PMA (Pre-Market Approval) for Class III implantable neuro-surgical devices to the FDA (Food and Drug Administration).
• Performing Root cause analysis through Ishikawa (Fishbone) diagram and Five-Why techniques to prepare Quality System Non-Conformance Report and determine requirement of a CAPA.
• Performing First Article Inspection of a new component to check GD&T dimensions conform with component drawing and conduct design inspection of a component in SolidWorks to check flat-blank dimensions conform to be able to bend at Press-Brake machine.
• Lead production continuous improvement projects focusing on lean manufacturing techniques 5s, Kanban, and Kaizen, to reduce bottlenecks on manufacturing process flow and enhance process efficiency.

Application

Send resume to amy.covely@draeger.com & must refer to “SQE”.

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.

Please apply directly through our career portal.
We look forward to receiving your application.

If you have any questions, please contact