Design Quality Engineer - Medical Device

Insight Global; Raynham (MA); On-site; USD 80,000 - 92,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

HSA

FSA

DCFSA

401k with employer matching

Paid time off

Job summary

Insight Global is seeking a design/quality engineer for the Spine product lifecycle, based in Massachusetts. The role focuses on leading design planning, requirements creation, and verification/validation activities for new and sustaining projects.

The engineer will drive risk management, apply statistical methods, and coordinate cross-functional reviews throughout the product development process to ensure compliance with QSR and ISO standards. A GMP/ISO background is essential.

Qualifications

• Bachelor’s degree in Engineering or Technical Science required.
• Minimum 3 years in GMP/ISO regulated industry preferred.
• Strong design/quality engineering skills across design control lifecycle.
• Experience in medical device/healthcare preferred.
• Solid knowledge of QSR (21 CFR 820) and ISO 13485, 14971 preferred.
• Blueprint literacy including GD&T preferred.

Responsibilities

• Join product development team focused on Spine business lifecycle management.
• Lead design and development planning for new and sustaining projects.
• Develop and validate functional/design requirements for projects.
• Conduct formal technical design reviews across development phases.
• Support design verification/validation including mechanical testing and analyses.
• Apply statistics and design-excellence tools to verification activities.
• Lead risk management planning and reporting across development and manufacturing.

Skills

GMP experience

Quality engineering

Design control

QSR (21 CFR 820)

ISO 13485/14971

GD&T literacy

Education

Bachelor’s Degree in Engineering/Technical Science

Master’s degree (plus)

Job description

Hiring Method: 14 Month Long Contract with opportunity for extensions.

Shift: 1st Shift (M-F)

Compensation: $57.58/hr to 66.76/hr.

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

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

EDUCATION & EXPERIENCE REQUIREMENTS:

• A minimum of a Bachelor’s Degree in Engineering and/or in a Technical Science is required. A Master’s degree is a plus.
• A minimum of 3 years related working experience in a GMP and/or ISO regulated industry is strongly preferred.
• Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management is required.
• Previous experience in a medical device or a healthcare discipline is strongly preferred.
• Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is strongly preferred.
• Blueprint literacy including GD&T preferred.

POSITION DUTIES & RESPONSIBILITIES:

• Product development team member focused on product development and life cycle management activities related to the clients Spine business.
• Lead design and development planning activities for new and sustaining projects.
• Participate in all aspects of the creation and execution of functional/design requirements for new and sustaining projects.
• Conduct formal technical design reviews throughout the phases of the product development process.
• Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.
• Apply statistical methods and design excellence tools to design verification and validation activities.
• Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting.
• Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes. He/she will support transfer to manufacturing activities both in product development and base businesses.
• Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement.