Design Quality Engineer

Are you a Design Quality Engineer looking to join one of the top companies in the Manufacturing industry?

Are you looking to further your career and grow?

Do you have experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical Class III devices?

If you answered yes to those three questions, then apply today!

Acara Solutions seeks highly qualified candidates to work onsite with our client in Newton, MA. Interested?

Here's what you'd do:

• 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, IEC 60601-1-2, and IEC 80601-2-77, as 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, or PMA submissions.
• Supporting the collection and analysis of performance metrics.
• Proposing and leading Corrective and Preventive Actions (CAPAs).
• Leading 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.

Here's what you'll get:

Pay: $56.48/hr.

Hours: 40 hours/week - 1^st shift.

Length: Temp (12 months).

Sounds like a good fit?

APPLY TODAY

About Acara Solutions

Acara is a premier recruiting and workforce solutions provider-we help companies compete for talent. With a legacy of experience across industries worldwide, we partner with clients, listen to their needs, and customize visionary talent solutions that drive the business outcomes they seek. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide.

• Bachelor's Degree in Engineering or Biomedical Engineering or Life Sciences.
• Minimum of 7 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.
• Minimum of 7 years of experience supporting the development of compliant medical device software or SaMD (i.e, IEC 62304/82304) and SWFMEA development.
• Minimum of 7 years of experience in applied statistics including use of Minitab or other statistical analysis software.
• Minimum of 7 years of experience in CAPA, NCMR, complaint investigations.

• Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971.
• Familiarity with electrical component handling and ESD controls.
• Experience with supporting De Novo/PMA submissions.
• 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.

Additional Information:

• Upon offer of employment, the individual will be subject to a background check and a drug screen.
• In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the necessary employment eligibility verification form upon hire.