Design Quality Engineer (Medical Device)-(USC/GC Only) (Auburndale)

Job Title:

Design Quality Engineer (Medical Device)-(USC/GC Only) Pay Rate:

$65 to $70/Hr Duration:

12 months Location:

Newton, MA

We are looking for a

Design Quality Engineer (Medical Device)

to join our Endovascular Robotics development group. New Product Development : Act as a Quality subject matter expert supporting the development of

sterile ,

single-use medical devices , with ownership of packaging,

sterile barrier systems ,

sterilization , and biocompatibility considerations to ensure compliance with applicable standards and internal quality system requirements. Support

risk management activities

in accordance with

ISO 14971 , including identification, analysis, mitigation, and documentation of risks throughout the design lifecycle within the Risk Management File. Support the development of Use, Design, and Process FMEAs to systematically identify and address potential failure modes and ensure appropriate risk controls are implemented. Support

design verification and validation activities , including development, review, and approval of test plans, protocols, and reports, with a focus on compliance testing for biocompatible, sterile, single-use consumable products (e.g.,

ISO

10993, IEC 60601-1, packaging and sterilization-related testing). Support the development and maintenance of the Usability Engineering File in accordance with IEC 62366 and applicable regulatory requirements. Support supplier qualification and process validation activities, including review of supplier documentation and quality outputs. Support test and inspection equipment evaluation, method development, and qualification activities as required. Support manufacturing transfer activities, including creation and review of DMR/DHR documentation and execution or review of validation protocols (IQ, OQ, PQ). Develop, review, and maintain work instructions, manufacturing procedures, and inspection documentation to ensure alignment with validated processes and design requirements.

Sustaining Activities : Support the collection, analysis, and trending of quality and performance metrics to identify opportunities for improvement. Propose, lead, and support

Corrective and Preventive Actions (CAPAs)

to address systemic issues and ensure effective resolution. Lead and/or participate in product complaint investigations, including root cause analysis and documentation of findings. Support the disposition of nonconforming material, including collaboration with cross-functional teams to determine appropriate actions.

Requirements: Bachelor’s degree in Engineering, Biomedical Engineering, or Life Sciences. 5–7 years of experience as a

Quality Engineer or Design Quality Engineer

in the

medical device

industry, supporting development and sustaining activities for sterile, single-use consumables and packaging. Hands-on experience with

ISO 10993-1, ISO 11607-1 , and ISO 11135 preferred. Working knowledge of

QMSR, ISO 13485, ISO 14971, IEC 62366 , and

MDD/MDR

requirements. Experience with applied

statistics , including the use of

Minitab

or equivalent statistical software. Demonstrated experience in

CAPA ,

nonconformance

management, and complaint investigations. Experience supporting De Novo and/or PMA submissions is preferred. Strong verbal and written communication skills, with the ability to author clear, concise, and technically sound procedures, protocols, analyses, and reports, and to collaborate effectively with internal and external stakeholders.