Quality Engineer II

Our Mission:

Through inspired engineering and design, we deliver outstanding solutions that positively impact lives. We use an interdisciplinary development process that combines our diverse engineering experience with creative industrial design solutions. We succeed when our partners succeed – it’s all about solving the most complex challenges by creating transformative technology.

Our Culture and People:

At Goddard, our most important asset is our people. We don't just work together; we thrive together. We foster a culture of collaboration, continuous learning, and mutual support. We believe in taking exceptionally good care of each other because great teams build great solutions. If you are someone who embodies the values of accountability, inspiration, dedication, efficiency, innovation, integrity, quality, and reliability, we want you on our team. Come be a part of a workplace where your ideas are valued, your growth is encouraged, and your contributions make a real impact. Join us in shaping the future of transformative technology – together.

Goddard is currently seeking a skilled Quality Engineer to join our team, where you will ensure that innovative medical technologies meet the highest standards of safety, security, and regulatory compliance. This role involves ensuring the quality, validation, and compliance of software systems within the highly regulated medical device industry. You will play a critical part in the development lifecycle of both product software (such as surgical robot control systems, cloud-based patient care networks, or mobile applications) and non-product software systems (NPSS) or Quality Management System (QMS) tools. This position requires a strong focus on product development, maintaining regulatory compliance, applying risk management, and fostering a culture of quality 

This is a salaried, full-time position located at our headquarters in Beverly, MA and will report to the Senior Quality Manager.  

The Role:

• Develop and Execute Test Procedures: Design, develop, and execute manual and automated software test procedures, scenarios, protocols, and scripts to verify design and product requirements. This includes determining test needs for the entire software development life cycle and planning overall test and regression suites. 

• Documentation and Deliverables: Author, review, and approve a range of quality assurance, software validation and verification deliverables, including validation plans, requirement test plans, protocols, results, risk assessments, traceability matrices, and summary reports. Ensure comprehensive and detailed documentation is created and maintained for regulatory compliance. 

• Regulatory Compliance & Standards Adherence: Monitor and ensure that regulations, protocols, procedures, and methodologies are followed. Apply strong knowledge of and comply with industry standards and regulations such as 21 CFR (including Part 11 and 820), ISO 13485, EU MDR, IEC 62304, ISO 14971, GAMP 5, and FDA guidelines. 

• Risk Management: Conduct and participate in product and software risk assessments, including FMEA (Failure Mode and Effects Analysis), to identify potential issues and determine tests to support mitigations. 

• Quality System Support & Improvement: Support the writing, deployment, management, and standardization of Quality Management System (QMS) processes, ensuring they are effective and compliant. Participate in or lead audits (internal and external) and CAPAs, providing validation documents and subject matter expertise. 

• Collaboration and Oversight: Work closely with cross-functional teams, including R&D, NPD, Integration, Software, Machine Learning, and Manufacturing, to assure quality in design for medical devices and application software. Provide guidance and mentorship on validation methods and quality assurance methods in software development. 

• Change Control: Review and approve change-control requests to assess potential quality system impact and ensure new software or changes are validated before approval and use. 

Qualifications:

Education:  

• Bachelor’s Degree in Engineering, Computer Science, IT-related field, or other scientific/technical discipline. 

• An advanced degree in Quality, Regulatory, or Software Engineering is highly preferred but not required.  

Preferred Experience: 

• 3-5+ years of experience in a software quality, software development, automated testing, or design quality engineering role, specifically within the medical device, pharmaceutical, or healthcare industry. 

• Expertise in the validation of enterprise-wide quality IT systems using established Computer System Validation (CSV) methodology. 

• Proven experience implementing and working with ISO/IEC 62304 (Medical Device Software Lifecycle), ISO/IEC 14971 (Risk Management for Medical Devices) and ANSI/AAMI SW96 (Security Risk Management for Medical Devices). 

• Experience with FDA regulations (21 CFR Part 820), EU Medical Device Regulations (EUMDR), and ISO 13485. 

• Demonstrated experience developing and executing manual and automated test suites. 

• Experience working in an Agile/Scrum development environment. 

• Technical Skills: Familiarity with test management tools such as DOORS, Jama, Jira, or Test Track Pro. Experience with various programming languages (e.g., C/C++/Python, Java, JavaScript) and testing frameworks is beneficial. 

• Soft Skills: Excellent communication skills (written and verbal), strong organizational skills, keen attention to detail and accuracy, and demonstrated project management competency. Ability to work effectively as an embedded team member or autonomously, with strong analytical and problem-solving abilities. 

What would make you a stand-out candidate:  

• Experience developing within a Secure Development Framework 

• Software Quality Engineer Certification (CSQE). 

• Experience with specific tools such as LabVIEW, TestStand, MATLAB, Git, Qt, or operating systems like Linux, IOS, and Android. 

• Prior experience testing robotic software systems. 

Our Benefits:

Flexible Time Off: Benefit from our generous flexible time off policy. We also provide sick leave and bereavement time because we understand that not all time off is for fun.

Retirement Savings: Invest in your future with a 401(k)-retirement plan. Goddard contributes 3% of your annual salary directly into your 401(k) account—regardless of your own contributions.

Health Coverage: Access to comprehensive medical, dental, and vision insurance for you and your family. Goddard contributes 80% of monthly premiums for all medical plan options.

Family Support: To take the time you need to welcome the newest member of your family, Goddard offer 6 weeks fully paid parental leave with support of PFML state programs.

Company Engagement: Engage with your colleagues through a variety of regular company and team events, including weekly social hours, Athletic Club outings, and department outings.