Find & Apply For Validation Engineer Jobs in Lexington, Massachusetts

6+ Month Contract to Hire M-F Onsite Job Summary We are seeking a Quality Engineer II with approximately 5+ years of medical device quality engineering experience to support the development, sustaining engineering, and manufacturing transfer of catheter and console products. This role will be responsible for ensuring new products, design changes, and existing products meet applicable regulatory and quality requirements throughout the product development and manufacturing lifecycle. The Quality Engineer will work closely with cross-functional teams and participate in activities spanning design development, verification and validation, risk management, manufacturing process development, complaint investigations, CAPA, and nonconforming material evaluation. Key Responsibilities Support sustaining engineering activities and quality engineering initiatives for existing medical device products. Participate in the development and implementation of new catheter and console products and design changes to existing products. Support complaint investigations, including investigation of product quality issues and identification of appropriate corrective actions. Lead or support CAPA activities, root cause investigations, and effectiveness checks. Evaluate and disposition nonconforming material in accordance with established quality procedures. Participate in all phases of the product development process, including design development, feasibility, verification, validation, and manufacturing transfer. Support Design Control activities, including design inputs, outputs, verification, validation, and design changes. Develop and/or review Process Validation documentation and protocols, including

IQ/OQ/PQ.

Support risk management activities, including FMEA and other risk analysis methodologies. Participate in product and process Risk Analysis activities and help ensure appropriate risk controls are implemented. Support reliability testing, early design feasibility testing, verification, and validation activities. Collaborate with R&D, Manufacturing, Operations, Regulatory, Quality, and other cross-functional teams to resolve technical and quality issues. Support manufacturing process development and manufacturing transfer activities. Ensure products and processes comply with applicable regulatory, quality, and company requirements. Review and contribute to quality documentation, reports, protocols, and engineering records. Identify opportunities for continuous improvement related to product quality, manufacturing processes, and quality systems. Required Qualifications Bachelor's degree in Engineering, Quality, Biomedical Engineering, or a related technical field. Approximately 5+ years of relevant Quality Engineering experience within the medical device industry. Hands-on experience with medical device quality systems and product development. Experience with complaint investigations, CAPA, and nonconforming material evaluation. Experience with Design Controls and medical device product development. Experience with Process Validation, including

IQ/OQ/PQ.

Experience with Risk Analysis and FMEA. Strong understanding of quality and regulatory requirements applicable to medical devices. Ability to work effectively with cross-functional engineering, manufacturing, quality, and regulatory teams. Strong technical documentation, problem-solving, and communication skills. Preferred Qualifications Experience with catheters, sterile disposables, or other single-use medical devices. Experience supporting sustaining engineering organizations. Experience with verification and validation (V&V) activities. Experience supporting manufacturing transfer and process development. Experience with reliability testing and design feasibility activities. Master's degree in Engineering or a related technical discipline. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

GRPB Pay:

$40.00 - $50.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance People with a criminal record are encouraged to apply

Work Location:

In person