Job Summary:
A leading healthcare technology organization is seeking a Senior Development Quality Engineer to support new product development initiatives for Class II medical devices with software components. This role will provide design quality expertise throughout the product lifecycle, ensuring compliance with regulatory standards, risk management practices, and quality system requirements. The position requires strong collaboration with cross-functional teams to support verification, validation, manufacturing, and commercialization activities.
Key Responsibilities:
- Lead and support completion of design control and development quality deliverables from concept through commercialization
- Drive risk management activities including risk assessments, software FMEA, and risk mitigation planning
- Support design verification and validation planning, execution, and issue resolution activities
- Develop, review, and approve test methods, validation protocols, and test reports
- Support software quality activities within Agile software development lifecycle environments
- Participate in reviews of system requirements, software requirements, firmware design, and code inspections
- Support software change management and overall product change control activities
- Collaborate with manufacturing teams on process development, qualification, and design transfer activities
- Support supplier qualification activities, component specifications, and sampling plans
- Participate in CAPA investigations, root cause analysis, and corrective action implementation
- Ensure Design History File documentation is complete, compliant, and audit-ready
- Support biocompatibility, sterilization, usability, and human factors activities as applicable
- Participate in internal and external audits and support continuous quality system improvements
- Ensure compliance with FDA regulations, ISO standards, and applicable global regulatory requirements
- Maintain strong cross-functional communication with engineering, manufacturing, suppliers, and quality teams
Required Qualifications:
- Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, Software Engineering, or related technical discipline
- Minimum of 5 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or Research and Development within medical devices
- Minimum of 2 years supporting product development and design quality activities
- Experience with design controls, risk management, and FMEA documentation
- Experience supporting software medical devices and software development lifecycle activities
- Experience with verification, validation, and test method development activities
- Knowledge of FDA regulations, ISO 13485, IEC 62304, ISO 14971, and medical device quality systems
- Experience working with Agile or iterative software development methodologies
- Familiarity with requirements management and issue tracking tools such as Jira, Jama, or DOORS
- Strong communication, collaboration, and organizational skills
Preferred Qualifications:
- Advanced degree in Engineering or related technical field
- Experience supporting active implantable or imaging medical devices
- Experience with cybersecurity design quality activities
- Knowledge of software testing, static code analysis, and automation frameworks
- Experience with CAPA investigations and root cause analysis methodologies
- ASQ Certified Software Quality Engineer or related certifications
- Exposure to programming or scripting languages such as Python, Java, C#, or Ruby
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $40/hr to $50/hr