Job DescriptionJob Description
At Modular Medical, our goal is to simplify diabetes management, ensuring that everyone has access to the superior care that insulin pumps offer. We believe that managing diabetes should be empowering, not intimidating. You shouldn't have to be a tech expert or a math genius to take charge of your health.
Please note: This is an on-site position is based in San Diego, CA. This role is not eligible for relocation assistance.
Role and Responsibilities: - Leading Software Quality Assurance activities throughout the Software Development Lifecycle for new product development initiatives.
- Ensures that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices
- Leads the non-product software tools Intended Use Validation (IUV) activities
- Provide guidance for the , review and approval of design control documentation with primary focus on software development deliverables
- Serve as the Software Design Control expert to various Medical Device development projects across the organization
- Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback
- Actively participate in Cybersecurity activities such as threat modeling and cybersecurity risk assessment
- Provide guidance on and participate in software development activities including requirements analysis and tracing, defect tracking and configuration management
- Support execution of Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304
- Participate and aid in software complaint investigations and analysis
- Ensure that software device quality and regulatory standards are met, including meeting FDA Part 820, ISO 13485, IEC 62304, MDR, and MDSAP requirements as applicable.
- Maintain effective communication with multiple stakeholders in the organization
- Collaborate with cross-functional teams, including manufacturing, engineering, regulatory affairs, and clinical operations, to identify and address quality-related issues and drive continuous improvement.
- All other duties as assigned
Education: BS Degree in Engineering or other related discipline
Experience: - A minimum of 6 years' work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
- Experience with medical device software development
- Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements.
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards
- Familiar with internal/External audits and regulatory inspections, including acting as an SME on the software development lifecycle (SDLC).
Skills (Required): - Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills
- Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Microsoft Office
Skills : - ASQ CSQE or other professional certifications
- Experience in the diabetes space
Physical: - Ability to sit or stand for extended periods of time
- Ability to infrequently lift and/or move up to 35 pounds
Note: Only local applicants with the legal right to live and work in the US will be considered for this position.
Compensation: The pay range for this position is $xxxxxx-$xxxxxx annually. The actual base pay offered may vary depending on several factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Additionally, we offer a comprehensive benefits package for our employees and their dependents, including medical, dental, vision, and life insurance, a generous PTO policy, and new hire stock options.
Application Policy: Modular Medical does not accept unsolicited resumes or applications from agencies. Please refrain from forwarding resumes to the Talent Acquisition team or employees. Modular Medical will not be responsible for any fees related to unsolicited resumes.
Equal Opportunity Employer: Modular Medical is an Equal Opportunity Employer. We embrace and are dedicated to fostering an inclusive environment for all employees. We do not discriminate based on status as a protected veteran, status as an individual with a , or any other legally protected characteristics.