Design Quality Engineer (Single Use Consumables)

Job Title: Design Quality Engineer (Single Use Consumables) (SIMNJP)

Duration: 02/06/2026 to 01/29/2027
Location: Newton MA USA 02466 Candidate must be able to work onsite.

Schedule: 40 hr work week. 9:00am - 5:00pm

Job Description:

Our Global Team: We are a team of 66000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of whats possible in healthcare to help improve peoples lives around the world. As a leader in the industry we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care is crucial for clinical decision-making and treatment pathways.

Our Culture: We are part of an incredible community of scientists clinicians developers researchers professionals and skilled specialists pushing the boundaries of whats possible to improve peoples lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Do you want to join us in helping to fight the worlds most threatening diseases and enabling access to care for more people around the world At company we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

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.

This is a role well suited to an ambitious professional looking for the next step in their career. As a Sr Design Quality Engineer (Consumables) you will be responsible for:

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.
Support other quality-related activities as assigned.

Required/Preferred skills to have for the success of this role:

Bachelors 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.