Design Quality Engineer

Overview

Position Overview:

The Design Quality Engineer will play a crucial role in ensuring the quality and compliance of Paragonix's medical device products throughout the design and development lifecycle. The successful candidate will collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to drive excellence in design control processes.

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time.

Paragonix also markets transplant services and organ screening to the transplant community.

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.

Annual Salary is 100K-110K with 5% STIP

Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes health, dental, and vision insurance benefits; a 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.

• Design Control Compliance: Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices.
• Risk Management: Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process.
• Failure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.
• Quality Planning: Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities.
• Design Input and Output: Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements. Validate that design outputs meet the specified design input requirements.
• Change Control: Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals.
• Verification and Validation: Develop and execute protocols for design verification and validation strategies and acceptance criteria. Collaborate with testing teams to ensure thorough testing of product designs.
• Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process.
• Regulatory Compliance: Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed.
• Continuous Improvement: Identify opportunities for process improvements within the design control system and contribute to the development and implementation of best practices.

• Bachelor's degree in engineering or a related field; advanced degree preferred.
• Minimum of 1-3 years of experience in a quality engineering role in the medical device industry.
• In-depth knowledge of design control processes, risk…