Senior Design Quality Engineer

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Senior Design Quality Engineer

Location(s): Newton, MA

Job Description
We are currently looking for an ambitious Senior Design Quality Engineer (Consumables) to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.

• 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.

• 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.
• Support other quality-related activities as assigned.

• 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 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.