Engineer II, Design 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.

The Engineer II, Design Quality is an active member of the Design Quality Engineering (DQE) Team who will provide design assurance support for our existing commercially released medical devices, as well as new product development projects. You will be part of a collaborative cross‑functional team, often consisting of members from Product Development Engineering, Clinical Affairs, Marketing, Regulatory Affairs, Production and Supplier Quality Engineering, Manufacturing Engineering, and Manufacturing, etc.,

to support new product development efforts, design changes, supplier changes, manufacturing and process changes, corrective and preventive actions (CAPAs), product complaint investigations, post‑market surveillance, risk management activities, and other compliance projects, such as EU MDR uplift of existing products. You will have the opportunity to learn about and work on a variety of medical devices, including chest drains, endovascular stents, and vascular grafts.

The main function of the DQE team is to ensure compliance to internal procedures and external regulations, standards, and guidances, and ensure design controls are met throughout the lifecycle of our devices. You will also provide SME input for risk management. You will ensure best practices are followed in documentation and design decisions to support successful audits by regulatory agencies.

This role consists mainly of review of product/project documentation and collaborative cross‑functional team discussion and decision making.

• Represent Quality initiatives and compliance when participating on design and development project teams, including in Design and Phase reviews.
• Provide guidance for the generation, review and approval of design control documentation and deliverables.
• Evaluate design control documentation (ex. requirements, specifications, FMEAs, verification/validation protocols and reports, etc.) to ensure compliance to external standards and regulations, as well as to internal procedures.
• Assist teams in developing robust user, product, and labeling requirements.
• Ensure that required standards for products are identified and documented in the product requirements specification and assist teams in demonstrating conformance to applicable standards.
• Provide expertise in evaluating design and process changes for impact to existing design control deliverables.
• Evaluate equipment documentation, maintenance, and calibration requirements for compliance to external standards and regulations, as well as internal procedures.
• Own risk management activities for device systems in compliance with ISO 14971, including risk management plans/reports, hazard/harm analyses, and FMEAs.
• Ensure the use of statistically valid sampling techniques.
• Support CAPA investigations and implementation of corrective actions.
• Support external audits (ex. scribing, screening documents).
• Remediate legacy products and documentation as required.

• Bachelor’s Degree in Engineering or Science, or equivalent work experience.
• A minimum of two years of related experience in medical device or QMS environment.

• Thorough knowledge of Quality System Regulations, ISO 13485, ISO 11607, ISO 14971, and other recognized international quality system standards and how they relate to design control, risk management, and other quality practices.
• Experience with statistics, SPC process control and ability to analyze data and interpret results.
• Sufficient analytical and problem solving skills.
• High level of attention to detail and accuracy.
• Demonstrated ability to resolve quality‑related issues in a timely and effective manner.
• Ability to prioritize and manage key deliverables in…