Essential Duties and Responsibilities:
- Lead design control and software development for medical devices, ensuring compliance with FDA and EU regulations.
- Support risk management activities in line with ISO14971 and IEC 62304 standards.
- Collaborate with various teams (software, hardware, UX, marketing, manufacturing, QA) to generate, document, verify, and validate requirements.
- Support and optimize design control and software development processes.
- Guide the creation, review, and approval of design control documents, focusing on software development.
- Support software tools and computerized systems validation used in production and quality processes.
- Participate in software development activities, including design and code reviews, requirements analysis, defect tracking, and configuration management.
- Ensure compliance to IEC 62304, FDA, and EU Guidance on Software Contained in a 510(k) or EU MDR/IVDR submissions
- Maintain effective risk management using feedback from various sources (validation, field service, post-market surveillance, etc.).
- Support the creation and review of medical device software documentation, including cybersecurity assessments.
- Ensure products comply with company procedures and global standards.
- Support inspection and testing in design and manufacturing.
- Assist with downstream processes like field service procedures and product returns.
- Review Design History Files and Technical Files for compliance.
- Support internal and supplier audits, NCR, and CAPA programs.
- Perform other duties as assigned
Required Education/Training and Experience:
- Bachelor’s degree in Electrical, Computer/Software, or Biomedical Engineering.
- Minimum of 7 years of experience in software quality engineering in a regulated environment.
- Preferred: ASQ-CSQE certification.
- Knowledge of FDA software guidance, ISO TR-80001, IEC 62304, and medical device standards.
- Experience with software development lifecycle methodologies and new product development.
- Strong analytical, problem-solving, and communication skills.
- Ability to work in a team and manage priorities in a fast-paced environment.
- Preferred: Knowledge of IEC 60601 medical device safety standards.
Knowledge, Skills, and Abilities:
- Experience with medical device software development
- Experience in Non-Product Software Validation, IQ OQ PQ
- Experience with a risk-based approach to validate computerized systems
- Detailed oriented and organized
- Skilled in written and verbal communication
- Highly responsive
- Ability to work in a team environment
- Highly motivated hands-on engineer with a proven record of meeting timelines and goals
- Must possess strong analytical & problem-solving skills
- Ability to manage priorities and meet deadlines in a fast-paced environment
- Must have strong analytical reasoning
- Must have problem solving capabilities.
- Self-driven individual who is capable and excited to learn about new technologies.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Relocate:
- Carlsbad, CA: Relocate before starting work (Required)
Work Location: In person
