What are the responsibilities and job description for the Development Quality Engineer position at Intellectt Inc?
Position: Sr. Development Quality Engineer
Location: Westford, MA (100% Onsite)
Duration: 12 Months Contract
Position Overview
The Sr. Development Quality Engineer acts as a key technical quality representative supporting product development teams in the medical device environment. This role provides design quality leadership across the product lifecycle to ensure patient safety, regulatory compliance, and high-quality product delivery from concept through commercialization. The position collaborates with cross-functional stakeholders to drive compliant and efficient product development for Class II imaging devices.
Top Technical Skills
- Design Controls & Risk Management – Strong experience with design control documentation, FMEAs, and risk management throughout product development
- Verification, Validation & Test Methods – Expertise in test method development, validation, and execution of design verification and validation activities
- Medical Device Quality & Regulations – Working knowledge of FDA, EU MDR, and medical device quality system requirements, including audit support and compliance activities
- Strong communication and cross-functional collaboration skills
Education
- Bachelor’s degree in Engineering or related technical field (Required)
- Master’s or advanced technical degree (Preferred)
Experience
- Experience in medical device product development
- Experience supporting Class II medical devices preferred
- Experience in imaging or diagnostic device development is a plus
- Strong background in new product development and quality engineering activities
Key Responsibilities
- Lead and support design control documentation and deliverables
- Collaborate with cross-functional teams to define clear and measurable product requirements
- Support design verification and validation planning, execution, and issue resolution
- Lead risk management activities from concept through commercialization
- Support test method development and validation efforts
- Work with manufacturing teams on process development and qualification
- Support component specifications, supplier sampling plans, and vendor qualification
- Assist in biocompatibility and sterilization qualification activities
- Participate in audits and quality system improvement initiatives
- Ensure compliance with FDA, EU MDR, and company quality standards
- Maintain effective communication with internal teams, suppliers, and stakeholders
Project Details
- Class II imaging device development
- Multiple ongoing imaging-related product development projects
- Focus on new product development and quality lifecycle support
Interview Process
- 1st Round: Microsoft Teams Video Interview (1–1.5 hours)
- 2nd Round: Onsite Interview with Hiring Manager and Team
- 3rd Round: Possible final round based on candidate progression