MD
Business Analyst
Macpower Digital Assets Edge Private Limited
🇺🇸 United States
On-site
5 days ago
$60 – $67 / hour
- Scrum
- IEC
- Risk Management
- ADO
- Jira
- CBAP
- HIPAA
- GDPR
5 days ago
ROLES & RESPONSIBILITIES:
- Collaborate with cross-functional teams, including product managers, systems engineers, software engineers and UX designer teams, to gather and document software requirements.
- ​Ensure traceability of requirements throughout the software development lifecycle, linking them to design, implementation, and testing phases.
- ​Ensure all software requirements comply with relevant regulatory standards, including IEC-62304.
- ​Translate business and regulatory needs into detailed functional and non-functional requirements for software development.
- ​Work closely with the software development team to ensure requirements are understood, feasible, and implemented correctly.
- ​Participate in risk management activities, including hazard analysis and risk assessment, to ensure the safety and efficacy of the software.
- ​Support the development of technical documentation required for regulatory submissions and audits.
- ​Stay up-to-date with the latest regulatory standards and industry best practices related to software as a medical device.​
- ​Bachelor's degree in Computer Science, Engineering, or a related field; advanced degree preferred.
- ​Minimum of 7+ years of experience in a business analysis role, preferably within the medical device industry.
- ​Excellent communication skills, both written and verbal, with the ability to interact effectively with technical and non-technical stakeholders.
- ​Experience with tools such as ADO, JIRA, JAMA or similar for requirements management and traceability.
- ​Familiarity with software development processes, particularly within an Agile framework.
- ​Excellent analytical, problem-solving, and communication skills.
- ​Ability to work collaboratively with cross-functional teams and manage multiple priorities.
- ​Strong knowledge of IEC-62304, FDA guidelines, ISO 14971, and other relevant standards for medical device software development is a plus.
- ​Certification in business analysis (e.g., CBAP, PMI-PBA) is a plus.
- ​Understanding of cybersecurity principles and data privacy regulations (e.g., HIPAA, GDPR) related to medical devices is a plus.
- ​Previous hands-on software development experience is a plus.
Business Analyst · Macpower Digital Assets Edge Private Limited