Sr. Engineer, Design Quality

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

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

 

Job duties:                Job Duties: Perform engineering duties in planning and designing mechanically functioning equipment (including medical devices). Oversee installation, operation, maintenance, and repair of equipment and systems within medical device industry. Support specification of system components or modification of products to ensure conformance with engineering design, performance specifications, or quality system regulations. Provide feedback to design engineers. Review and analyze testing of the feasibility, design, operation, or performance of equipment, components, or systems. Review performance requirements for product development or engineering projects. Provide design assurance support for our existing commercially released medical devices, as well as new product development projects. 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. Learn about and work on a variety of medical devices, including chest drains, endovascular stents, and vascular grafts. Ensure compliance to internal procedures and external regulations, standards, and guidance, and ensure design controls are met throughout the lifecycle of our devices. Provide SME input for risk management. Ensure best practices are followed in documentation and design decisions to support successful audits by regulatory agencies. Review product/project documentation and collaborative crossfunctional team discussion and decision-making.

 

Requirements:           Requirements: Bachelor's degree in Engineering or Science plus 5 years of experience in in the medical device industry. Requires skills and experience in the following:

• 1 year of experience with statistics, SPC process control, and the ability to analyze data and interpret results;
• Firm understanding of Quality System regulations including; 21 CFR Part 820, ISO 13485, ISO 14971 and other recognized international quality systems standards and how they relate to design control, risk management and other quality practices; and
• Strong computer skills with MS Office (Word, Excel, and PowerPoint); and Experience with statistical software such as Minitab.

Employer will accept any suitable combination of education, training or experience.

 

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted MedTec company.

 

Benefits at Getinge:

 

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

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

 

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.