Design Quality Engineer

Insight Global; Raynham (MA); Hybrid; USD 69,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan after 90 days

Paid sick leave and PTO

Job summary

Insight Global is hiring a Design Quality Engineer to support a medical device client in Raynham, MA.

This hybrid role requires 3 days onsite weekly and entails working with Product Development, Regulatory Affairs, Manufacturing, Marketing, and Quality teams to ensure compliance with Design Control, Risk Management, and Quality System requirements.

Qualifications

• 3+ years of Design Quality Engineering or related experience in a regulated industry.
• Experience with design controls and product lifecycle.

Responsibilities

• Support new product development and sustaining engineering activities within a regulated medical device environment.

Skills

Design Controls

V&V (Verification & Validation)

Risk Management

FDA 21 CFR Part 820

ISO 13485

Root Cause Analysis

Quality System

Cross-functional Collaboration

Six Sigma / Lean

Design Reviews

Education

Bachelor's degree in Engineering or related field

Master's degree in Engineering or related field

Job description

Job Description

Insight Global is hiring a Design Quality Engineer to support a medical device client out of Raynham, MA. This role is hybrid, with 3 days per week onsite. The Design Quality Engineer will serve as a key member of the product development team, supporting both new product development and sustaining engineering initiatives within a regulated medical device environment. This individual will partner closely with Product Development, Regulatory Affairs, Manufacturing, Marketing, and Quality teams to ensure products are developed and maintained in accordance with Design Control, Risk Management, and Quality System requirements. The ideal candidate brings strong experience in design quality engineering, design verification and validation, risk management, and medical device regulations.

Day-to-Day Responsibilities

• Partner with cross-functional product development teams to support new product development and lifecycle management activities.
• Lead design and development planning activities for new and sustaining engineering projects.
• Participate in the development and execution of design inputs, design requirements, and design control deliverables.
• Conduct and facilitate technical design reviews throughout all phases of product development.
• Review, support, and approve design verification and validation (V&V) activities, including mechanical testing, tolerance analyses, design rationale documentation, and anatomical lab evaluations.
• Apply statistical methodologies and design excellence tools to support verification and validation efforts.
• Lead and support risk management activities, including product design risk assessments, clinical risk evaluations, production risk management, and risk summary reporting.
• Drive the translation of critical-to-quality (CTQ) product characteristics into quality plans and downstream manufacturing controls.
• Support product transfers to manufacturing and collaborate on design-for-manufacturing initiatives.
• Drive continuous improvement efforts related to Design Controls, Risk Management, and Quality System processes.
• Provide quality leadership in investigations, CAPA activities, product complaints, nonconforming material reviews, post-market surveillance, and audit support activities.
• Serve as a quality and regulatory resource for cross-functional teams, ensuring alignment with applicable medical device regulations and quality standards.

Compensation

$50/hr to $58/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [e-mail] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Bachelor's degree in Engineering, Technical Science, or a related discipline.
• 3+ years of experience in Design Quality Engineering, Quality Engineering, or Product Development within a regulated industry.
• Strong understanding of Design Controls and the product development lifecycle.
• Experience supporting design verification and validation (V&V) activities.
• Experience with product risk management and risk assessment methodologies.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 requirements.
• Strong root cause analysis, problem-solving, and decision-making skills.
• Experience collaborating across Engineering, Manufacturing, Regulatory, and Quality teams.
• Proficiency with Microsoft Office applications.
• Medical device industry experience.
• Experience supporting orthopedic, spine, surgical, implantable, or other highly regulated medical products.
• Working knowledge of ISO 14971 risk management requirements.
• Experience leading or participating in technical design reviews.
• Blueprint reading and GD&T interpretation experience.
• Familiarity with Design Excellence, Six Sigma, Lean, or other quality engineering tools.
• Experience supporting product transfers and manufacturing readiness activities.
• ASQ or other relevant quality certifications.
• Master's degree in Engineering or a related technical field.