Design Quality Engineer; Single Use Consumables Job Newton area,Massachusetts USA,Engineering

Position: Design Quality Engineer (Single Use Consumables)

Job Description :

Pay Range: $65hr - $70hr

The Design Quality Engineer will serve as a Quality subject matter expert supporting the development of sterile, single-use medical devices.
This role has ownership of packaging, sterile barrier systems, sterilization, and biocompatibility considerations to ensure compliance with applicable standards and internal quality system requirements.
The position supports both new product development and sustaining quality activities, ensuring products meet regulatory and quality expectations throughout the lifecycle.

Responsibilities:

Act as a Quality subject matter expert for sterile, single-use medical devices, including packaging, sterile barrier systems, sterilization, and biocompatibility.
Support risk management activities in accordance with ISO 14971, including risk identification, analysis, mitigation, and documentation within the Risk Management File.
Support development of Use, Design, and Process FMEAs to identify potential failure modes and implement appropriate risk controls.
Support design verification and validation activities, including development, review, and approval of test plans, protocols, and reports, with emphasis on compliance testing for biocompatible and sterile consumables.
Support development and maintenance of the Usability Engineering File in accordance with IEC 62366 and regulatory requirements.
Support supplier qualification and process validation activities, including review of supplier documentation and quality deliverables.
Support evaluation and qualification of test and inspection equipment and method development activities.
Support manufacturing transfer activities, including review and creation of device documentation and execution or review of validation protocols such as IQ, OQ, and PQ.
Develop, review, and maintain work instructions, manufacturing procedures, and inspection documentation aligned with validated processes and design requirements.
Support collection, analysis, and trending of quality and performance metrics to identify improvement opportunities.
Propose, lead, and support Corrective and Preventive Actions to address systemic issues and ensure effective resolution.
Lead or participate in product complaint investigations, including root cause analysis and documentation.
Support disposition of nonconforming material in collaboration with cross-functional teams.
Support additional quality-related activities as assigned.

Experience:

Five to seven years of experience as a Quality Engineer or Design Quality Engineer in the medical device industry.
Experience supporting development and sustaining activities for sterile, single-use consumables and packaging.
Hands-on experience with biocompatibility, packaging validation, and sterilization standards preferred.
Experience with applied statistics and statistical software such as Minitab or equivalent.
Demonstrated experience in CAPA, nonconformance management, and complaint investigations.
Experience supporting regulatory submissions such as De Novo or PMA is preferred.

Skills:

Working knowledge of quality management systems and medical device regulations, including ISO 13485, ISO 14971, IEC 62366, and applicable regulatory requirements.
Strong understanding of risk management, validation, and compliance testing processes.
Strong verbal and written communication skills with the ability to author clear, concise, and technically sound documentation.
Ability to collaborate effectively with internal and external stakeholders.

Qualification And Education:

Bachelor s degree in Engineering, Biomedical Engineering, or Life Sciences.


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