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# Design Quality Engineer

- **Company:** Atrium Medical Corporation
- **Location:** Waltham, MA, United States
- **Experience:** Starter
- **Salary:** $100,000.0 - $110,000.0
- **Contract:** Permanent contract
- **Skills:** Microsoft Excel, Adobe InDesign, Computer Literacy, Microsoft Office, Minitab, Verification and Validation (Software), Statistical Process Control (SPC), Strategies of Testing, JMP (Statistical Software)
- **Published:** October 28, 2026
- **Apply:** https://jobs.localjobnetwork.com/apply/add/88735715/1

## About the Role

\* 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. \* DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus. Other Requirements: \* 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). \* Effective verbal and excellent technical writing skills. \* Excels at generating and maintaining organized and accurate records. \* Excellent oral and written communication skills in English. \* Able to travel domestically and internationally as required (\<10%) \* Able to work in the US without sponsorship now or any time in the future.



## Description

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 Sustaining Engineering, R&D, manufacturing, regulatory affairs, and quality assurance, to drive excellence in design control processes.

Primary responsibilities/authority will include:

 * 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.
 * 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.
 * Failure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.