Quality Engineer

The Quality Engineer will support the development, design changes, verification, validation, and manufacturing transfer of catheter and console medical device products. The role works closely with cross-functional teams to ensure products meet applicable regulatory, quality, design control, and risk management requirements throughout the product lifecycle.

• 3+ years of Quality Engineering experience in the Medical Device industry.
• Experience with catheters, sterile disposables, or similar medical devices preferred.
• Experience with Design Controls and Risk Management.
• Strong knowledge of FMEA and risk analysis.
• Hands-on experience with Process Validation, IQ/OQ/PQ.
• Experience with CAPA and complaint investigations.
• Experience evaluating nonconforming materials.
• Experience supporting sustaining engineering and product changes.
• Strong cross-functional communication and problem-solving skills.
• Ability to participate in an onsite interview in Lexington, MA; candidates should be reasonably local.
• Bachelor's in Biotechnology, Chemistry, Life Science.

Skills:

• Medical Device industry
• 3+ years of experience
• Complaint investigations
• CAPA's
• Evaluating nonconforming material
• Experience with catheters or sterile disposables
• Process Validation, IQ/OQ/PQ
• Design Control
• Risk Analysis
• FMEA
• Sustaining engineering
• This role will be responsible for ensuring the new catheter and console products and design changes to existing products meet regulatory and quality requirements throughout the design, development, and manufacturing transfer process.
• This will be accomplished through close collaboration with cross-functional teams. The Quality Engineer participates in all phases of the product development process.
• This includes development, reliability testing, design controls, input requirements, early design feasibility testing and verification and validation, manufacturing process development activities, product risk management requirements, and delivery.