Design Quality Engineer (Electromechancial)

Newton, MA - USA

Monthly Salary: Not Disclosed

Posted on: 7 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 (Electromechancial)

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 (contractor) 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 (contractor) you will be responsible for:

Serve as the Quality representative and Design Controls lead on cross-functional teams developing complex electromechanical and robotic medical systems.
Own and support Design Control activities across the product lifecycle in accordance with FDA QSR (21 CFR 820.30) ISO 13485 and applicable regulations.
Support definition and approval of system- and subsystem-level design inputs that are clear testable and aligned to intended use and risk.
Maintain end-to-end traceability between design inputs outputs risk controls verification and validation.
Support design reviews phase gate readiness and Design History File (DHF) completeness.
Lead and support risk management activities per ISO 14971 using a system-level top-down and bottom-up approach.
Ensure risk controls are implemented and verified and residual risk is supported by objective evidence.
Support tolerance worst-case and margin analyses as inputs to risk assessment and verification planning.
Provide Quality oversight of design verification and validation (V&V) planning execution and reporting.
Review and approve V&V protocols and reports to ensure adequate coverage of requirements risks and regulatory expectations.
Support electrical safety and EMC compliance testing including IEC 60601-1 IECand IECas applicable.
Collaborate with Software Quality and Systems Engineering to ensure HW/SW integration risks are addressed.
Support supplier qualification and design transfer for design-critical components and interfaces.
Support preparation and review of Design Control risk and V&V documentation for IDE De Novo and/or PMA submissions.

Sustaining Activities-

Supporting the collection and analysis of performance metrics.
Proposing and leading Corrective and Preventive Actions (CAPAs).
Leading and/or participating in product complaint investigations leading to root cause.
Assisting in the dispositioning of non-conforming material.
Supporting other duties as assigned by manager.

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

Minimum 4-year degree in Engineering Biomedical Engineering or Life Sciences.
7 to 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical Class III devices is required.
Working knowledge of QSR MDD/MDR ISO-13485 and ISO-14971 is required.
Experience supporting the development of compliant medical device software or SaMD (i.e IEC 62304/82304) and SWFMEA development is required.
Experience in applied statistics including use of Minitab or other statistical analysis software is required.
Experience in CAPA NCMR complaint investigations is required.
Familiarity with electrical component handling and ESD controls is required.
Experience with supporting De Novo/PMA submissions is preferred.
Effective and professional communication skills with both internal and external stakeholders.
Effective written communication skills with the ability to author clear concise and accurate procedures analyses protocols and reports.
Effective time/task management skills; excel working in a fast-paced environment.

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...