Design Quality Engineer

Getinge•Waltham, MA

3d•$100,000 - $110,000

About The Position

The Design Quality Engineer will ensure the quality and compliance of Paragonix Technologies’ medical device products throughout the design and development lifecycle. The role collaborates with Sustaining Engineering, R&D, manufacturing, regulatory affairs, and quality assurance to maintain effective design control processes and support the development of safe and effective medical devices. Paragonix Technologies markets organ transportation devices that use cold preservation techniques and a suspension system to protect organs during transport. The position also supports regulatory compliance, product verification and validation, continuous improvement of design control processes, and post-market surveillance activities, including failure investigation, record review, and data trending. Domestic and international travel may be required at less than 10%.

Requirements

Bachelor’s degree in engineering or a related field.
At least 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, including ISO 13485, ISO 14971, and FDA QSR.
Technical skills in product quality, including translating voice of the customer into design specifications, human factors, CTQ cascades, design characterization, verification and validation, test method validation, process validation, inspection techniques, and statistics.
Strong understanding of medical device regulatory requirements, including FDA and EU MDR.
Excellent communication and interpersonal skills, with the ability to collaborate across functions.
Proficiency with MS Office, specifically Excel.
Effective verbal communication and strong technical writing skills.
Ability to generate and maintain organized and accurate records.
Excellent oral and written communication skills in English.
Ability to travel domestically and internationally as required, less than 10%.
Ability to work in the United States without sponsorship now or at any time in the future.

Nice To Haves

Advanced degree preferred.
DFSS or DMAIC Black Belt, ASQ Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA) certification.
Electrical and mechanical background.
Experience creating and analyzing charts in Minitab, JMP, or equivalent software.
Knowledge of Six Sigma, Lean, SPC, ASQ, and/or ISO process controls.

Responsibilities

Implement and maintain design control processes in accordance with applicable standards and regulations, including ISO 13485, ISO 14971, FDA QSR, and MDR.
Lead and contribute to risk management activities, including risk identification, assessment, and mitigation, and integrate risk management into the design process with R&D.
Develop and execute quality plans for new product development projects, defining quality objectives, deliverables, and verification and validation activities.
Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements.
Validate that design outputs meet specified design input requirements.
Manage design changes by evaluating their impact on product quality, ensuring documentation, and obtaining required approvals.
Develop and execute design verification and validation protocols, strategies, and acceptance criteria.
Collaborate with testing teams to ensure thorough testing of product designs.
Work with R&D, manufacturing, regulatory affairs, and quality assurance to promote effective communication and collaboration during product development.
Monitor relevant regulations and standards and ensure product designs comply with applicable requirements; support regulatory submissions as needed.
Identify opportunities to improve the design control system and contribute to best practices.
Assist with post-market surveillance activities, including failure investigations, record review, and data trending.