Sr. Engineer, Design/Software Quality

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

The Sr. Engineer, Design/Software Quality is an active member of the Design Quality Engineering (DQE) team who will serve a dual role to both provide design assurance support for our existing commercially released or new product development medical devices, as well as provide direction and support to Quality Management System (QMS) software projects.

 

For the DQE part of the role, you will be part of collaborative cross-functional teams, often consisting of members from Product Development Engineering, Clinical Affairs, Marketing, Regulatory Affairs, Production and Supplier Quality Engineering, Manufacturing Engineering, and Manufacturing, etc. The incumbent will support new product development efforts, design changes, risk management activities, supplier changes, manufacturing and process changes, corrective and preventive actions (CAPAs), product complaint investigations, post-market surveillance, in addition to other compliance and continuous improvement projects.  This role consists mainly of review of product/project documentation and collaborative cross-functional team discussion and decision making. You will have the opportunity to learn about and work on a variety of medical devices, manufactured at the Merrimack site.

 

For the QMS software part of the role, you will be part of collaborative cross-functional teams, often consisting of members from IT and Engineering and/or Manufacturing, to support software needs from implementation of new software to changes to existing software utilized for the QMS. This role will be responsible for ownership of the QMS software processes of the site, identification of bugs, defects, and issues through testing and analysis including maintenance and continuous improvement of the procedures. You will also be responsible for participating on and leading QMS software projects, often providing mentorship and guidance to the software system owners. This role should have technical background in software, infrastructure of applications, and overall guidances/regulations related to software.

 

This role is to ensure compliance to internal procedures and external regulations, standards/guidances, and ensure design and software controls are met throughout the lifecycle of our medical devices and QMS software. You will ensure best practices are followed in documentation and design decisions to support successful audits by regulatory agencies.

 

 

Who You Are:

Someone with a background in medical devices, with strong knowledge of ISO 13485 and 21 CFR 820 and how they relate to design control, risk management, QMS software, and other quality practices. You have experience with the product and QMS software development lifecycle, assessment and implementation of design and QMS software changes, and maintaining compliance to external standards and regulations. You also have working knowledge of ISO 14971 and experience with risk management tools such as FMEA. You are familiar with creating design inputs and software requirements, performing Design Verification and Validation, performing QMS software IQ/OQ/PQs, performing Test Method Validation, conducting design and code reviews, and supporting design transfer to manufacturing. You have familiarity with statistical analysis techniques and sampling plans.

 

You have strong technical writing skills, experience in root cause analysis, and extreme attention to detail but also have the ability to see the "big picture" i.e. how each part of a project feeds into the design control and QMS software processes overall. You have the ability to, manage multiple priorities, and work well under pressure and in a fast-paced environment.  You are an individual that is self-driven, possesses a strong desire to learn, strives for excellence, and always keeps quality and the customer in mind in everything you do.