Design Quality Engineer

Getinge•Boston, MA

3d•$100 - $110•Hybrid

About The Position

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. 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. 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.

Requirements

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 management, and quality management systems (ISO 13485, ISO 14971, FDA QSR).
Strong technical skills related to product quality including VOE translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.
Strong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.).
Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
Effective verbal and excellent technical writing skills.
Excellent oral and written communication skills in English.
Able to travel domestically and internationally as required (<10%)

Nice To Haves

DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.
Electrical and mechanical background strongly preferred.
Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.
Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus.
Computer proficiency in MS office (specifically Excel).
Excels at generating and maintaining organized and accurate records.

Responsibilities

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.