Senior Product Security Engineer
Medtronic
CloudCyber SecuritySDLC
Staff Engineer, Software Design Assurance, Medical Device
Abbott
full-time
Posted on:
Origin: • 🇺🇸 United States • California, Massachusetts
Visit company websiteSalary
💰 $97,300 - $194,700 per year
Job Level
Lead
Tech Stack
CloudCyber Security
About the role
- Provide oversight of R&D design control deliverables for development of medical product software (Cloud Patient Care Networks, mobile applications and embedded software), non-medical software, and non-product software.
- Support software verification and validation activities for new products and software changes in accordance with plans.
- Review and approve of requirements, software test case protocols/reports, software development plans, and other system and software documentation.
- Participate in meetings to evaluate, prioritize, and develop action plans for addressing software defects/bugs captured in the problem resolution systems.
- Perform risk assessments and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues.
- Participate in technical and management reviews to ensure design plans, product designs, and deliverables related to product software are met.
- Represent the Global Design Quality Department for final review and approval of project deliverables.
- Support non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
- May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
- Work as an individual contributor and provide guidance or oversee work of other Software Quality team members.
- Support audits and lead quality system improvement activities.
- Comply with U.S. Food and Drug Administration (FDA) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, and procedures.
Requirements
- Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
- Minimum 8 years of Software Development and Design Quality Engineering experience or an equivalent combination of education and experience.
- Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (e.g., 62304), EU Medical Device Regulations and MDSAP
- Experience with medical device software development lifecycle for Cloud-based networks and/or mobile applications.
- Experience using requirements management tools (e.g., DOORS) and using problem reporting systems (e.g., JIRA). (Preferred)
- Hands-on experience with FMEA/risk management. (Preferred)
- Experience developing or maintaining design controls for software development. (Preferred)
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