Design Quality Engineer (Single Use Consumables)

Newton, MA - USA

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan offering strategic talent solutions to clients worldwide. The opportunity below is with one of our clients a leading global medical technology company. This organization provides a wide range of diagnostic imaging and laboratory diagnostics as well as advanced therapies and digital health services. Its solutions span prevention and early detection through diagnosis treatment and follow-up care empowering healthcare providers worldwide.

Job Title: Design Quality Engineer (Single Use Consumables)

Location: Newton MA 02466

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: 9AM-5PM

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.
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:

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.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan offering strategic talent solutions to clients worldwide. The opportunity below is with one of our clients a leading global medical technology company. This organization provides a wide range of diagn...