Hybrid Medical Device Design Quality Engineer

Getinge Group; Waltham (MA); Hybrid; USD 100,000 - 110,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Life Insurance

Job summary

Paragonix Technologies, Inc. is seeking a Design Quality Engineer in Waltham, MA to ensure quality and regulatory compliance across the design and development lifecycle. You will work with cross-functional teams, implementing design controls and leading risk management to deliver safe medical devices.

The role requires 1–3 years in medical device quality engineering, knowledge of ISO 13485/14971 and FDA QSR, plus strong analytical and writing skills. Hybrid work with US travel up to 10%.

Qualifications

• Bachelor's degree in engineering or related field; advanced degree preferred.
• In-depth knowledge of design controls, risk management and quality systems (ISO 13485, ISO 14971, FDA QSR).
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Implement and maintain design control processes per regulatory standards (ISO 13485, ISO 14971, FDA QSR, MDR).
• Lead risk management activities and integrate into design process.
• Develop and execute quality plans for new product development projects; define verification/validation activities.
• Review and approve design inputs; ensure outputs meet input requirements.
• Manage design changes with proper documentation and approvals.
• Develop/execute protocols for design verification and validation with testing teams.
• Collaborate with R&D, manufacturing, regulatory affairs, and QA across development lifecycle.
• Stay current with regulatory requirements and support regulatory submissions.
• Identify opportunities for process improvements in the design control system.
• Assist in PMS activities including failure investigations and data trending.

Skills

Design Control Knowledge

Risk Management

Quality Management Systems

Regulatory Compliance

Communication & Collaboration

DFSS/DMAIC Black Belt

ASQ CQE/CQA Certification

Education

Bachelor's degree in engineering or related field

Advanced degree preferred

Tools

Minitab

JMP

Excel

Job description

Paragonix Technologies, Inc. is seeking a Design Quality Engineer in Waltham, MA to ensure quality and regulatory compliance across the design and development lifecycle. You will work with cross-functional teams, implementing design controls and leading risk management to deliver safe medical devices.

The role requires 1–3 years in medical device quality engineering, knowledge of ISO 13485/14971 and FDA QSR, plus strong analytical and writing skills. Hybrid work with US travel up to 10%.