Senior Software Design Quality Engineer

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

Job Title: Senior Software Design Quality Engineer
Start Date: ASAP
Salary Range: $110,000 - $160,000/year
Travel: Onsite 3 days per week in Danvers, MA

Must be authorized to work in the U.S. This position is not eligible for sponsorship.

The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls.

This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed.

Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech.

Key Responsibilities

• Drive quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
• Use Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) technical expertise, knowledge, and experience to rapidly innovate the company's medical devices for use in chronic heart failure patients.
• Lead and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
• Drive assessments of end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include but are not limited to software detailed designs, software architecture and specifications.
• Ensure that Design Controls are compliant with IEC 62304.
• Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development and testing.
• Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables.
• Develop and/or review test protocols, reports, and engineering summaries
• Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.
• Review and approve Change Requests as needed to release software revisions to production/field.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
• Drive the success of the Quality System performance measures by completing tasks on time and with a high level of Quality
• Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.
• Support 3rd party audits, including follow-up on actions.
• Drive compliance of QMS through authoring and updating Standard Operating Procedures (SOP).

Qualifications

Education

A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.

Experience and Skills

• A minimum of 5 years of related work experience within the medical device industry on SaMD and SiMD systems.
• Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
• Experience with software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regulated medical device industry.
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.

Preferred Qualifications

• Work experience with Class III medical device capital equipment development
• Experience with owning, conducting and maintaining risk management activities, including the risk management file.
• Experience with JAMA and Atlassian suite of tools (JIRA/Confluence)
• Experience with cybersecurity within a regulated industry.

Benefits

• Health
• Dental
• Vision
• 401K
• PTO

Other

This position will require to work hybrid in Danvers, MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.