Principal Engineer, 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.

Job Overview

The Principal Engineer, 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 / Sustaining Engineering, Clinical Affairs, Regulatory Affairs, Marketing, Production and Supplier Quality Engineering, Manufacturing Engineering, and Manufacturing, etc., to 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, 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.

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, and other quality practices. You have experience with the product development lifecycle, assessment and implementation of design 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 FMEAs. You are familiar with creating design inputs, performing design verification and validation, performing process and test method validation, conducting design 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 you have 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 process overall. You have the ability to learn quickly, manage multiple priorities, and work well under pressure and 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.

Job Responsibilities and Essential Duties

• Supervise / manage junior Design Quality Engineers, including selecting, training, scheduling, monitoring, and evaluating staff.
• Lead quality initiatives and compliance when participating on design and development project teams, including in Design and Phase reviews.
• Own risk management activities for device systems in compliance with ISO 14971, including risk management plans / reports, hazard / harm analyses, and FMEAs.
• Lead continuous improvement efforts related to design controls, risk management and other quality functions.
• 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.
• Ensure the use of statistically valid sampling techniques; Teaches others on the use of these and other advanced statistical techniques such as DOE and ANOVA.
• Participates in and represents the Design Quality Engineering function during audits by 3rd parties.
• Support CAPA investigations and implementation of corrective actions.
• Remediate legacy products and documentation as required.

Minimum Requirements

Required Knowledge, Skills and Abilities

Supervision / Management Of Others :

Internal and External Contacts / Relationships

Environmental / Safety / Physical Work Conditions

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Annual salary of 115K to 140K with 15% STIP

#LI-YA2 #LI-Hybrid

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge :

At Getinge, we offer a comprehensive benefits package, which includes :

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.