Senior MedTech Software Design & Quality Engineer (Hybrid)

Mondo; Danvers (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health

Dental

Vision

401K

PTO

Job summary

Mondo in Danvers, MA is seeking a Senior Software Design Quality Engineer to support New Product Development and sustaining activities. You will manage risk, cybersecurity, change controls, test reviews, and design controls within a collaborative, fast-paced team.

The role emphasizes software quality, regulatory knowledge, and cross-functional communication across a dynamic MedTech environment. Hybrid work with onsite presence in Danvers, MA is required.

Qualifications

• Minimum 5 years in the medical device industry (SaMD/SiMD).
• Experience with quality systems and regulatory standards (21 CFR 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP/MDD/MDR).
• Familiarity with SDLC in regulated environments (waterfall, Agile, DevOps).
• Excellent written and verbal communication within cross-functional teams.

Responsibilities

• Drive design and development of software within the SDLC with traceability.
• Lead risk management plans, SFMEA, and risk reports for SaMD/SiMD.
• Define requirements and design targets for software architecture and specs.
• Ensure Design Controls comply with IEC 62304 and regulatory requirements.
• Apply FDA/regulatory knowledge to risk, development, and testing.
• Support SCRUM events and provide feedback on verification and validation.
• Develop/review test protocols and engineering summaries.
• Participate in cybersecurity activities including threat analysis and risk assessments.
• Review and approve Change Requests for production releases.
• Solve quality issues with systematic problem-solving methods.
• Support CAPA activities and manage CAPA system.
• Assist 3rd party audits and follow-up on actions.
• Drive QMS compliance through SOPs.

Skills

Quality engineering

SaMD/SiMD

Regulatory knowledge

Risk management

Software lifecycle

Communication

Education

Bachelor's degree in engineering

Advanced degree asset

Tools

JIRA

Confluence

Job description

Mondo in Danvers, MA is seeking a Senior Software Design Quality Engineer to support New Product Development and sustaining activities. You will manage risk, cybersecurity, change controls, test reviews, and design controls within a collaborative, fast-paced team.

The role emphasizes software quality, regulatory knowledge, and cross-functional communication across a dynamic MedTech environment. Hybrid work with onsite presence in Danvers, MA is required.