Business Analyst at Comtec Consultants

Business Analyst III

12 Months

3721 Valley Centre Drive-San Diego CA

Description:

You are responsible for
• 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.


You are a part of
Ambulatory Monitoring and Diagnostics Heart, R&D organization. As a Technical Business Analyst, you’ll be a part of highly collaborative, cross-functional Scrum teams within the ECG Solutions group. You will help enable teams in their continued journey through SAFe, to think creatively, take risks and consider the “What if...” scenario all the while ensuring that the squad is fully functional, productive, and focused on sprint and PI goals.

To succeed in this role, you’ll need a customer-first attitude and the following
• 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 (RTM)
• 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.

Sr. Design Assurance Engineer

Pittsburgh, PA onsite/hybrid

12 Months

Key Areas of Responsibility (KARs):

• Ensures that appropriate quality, reliability and Post Market-Surveillance (PMS) plans are made and include all stages of the product life cycle
• Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone.
• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the quality, reliability, PMS Plans, any Risk Management activities, and all of design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and initiates field actions when required
• Supports stakeholders during the execution of quality system and product audits and inspections.
• Required Competencies:

• DESIGN quality experience. Sustaining product changes, product development (design inputs, design outputs, hazard analysis, design verification, design validation, design transfer, analysis of impact to quality/safety of design changes, coaching teams through use of design controls), DHF remediation.
• Quality Management
• Risk Management
• Design Controls and change Management
• Quality Assurance
• Quality Engineering
• Verification/ Validation- Design Transfer

Education and Experience Requirements:-

• Bachelors degree in engineering
• Working knowledge of appropriate global regulations, requirements, and standards.
• 3 years of related experience in a medical device or other regulated industry.

Job Overview:

• Independently Produces and completes Quality Engineering Documents.
• Responsible for performing timely, quality engineering tasks like: Assessing quality plans, assessing product designs, and reviewing test and other performance data, analyzes market feedback, lead root cause analysis and quality problem solving.
• May also provide other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Fully qualified quality engineer who has advanced beyond entry level.
• Has working knowledge of company products and services.
• Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules
• Works on issues of diverse scope where analysis of situation of data requires evaluation of a variety of factors, including an understanding of current business trends.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
• Acts as advisor to junior quality engineers
• Collaborates with the following main stakeholders with regards to the KARs: R&D Engineers, Post Market Surveillance investigators, Risk Management engineers, Product Support Engineers, Regulatory Affairs Specialists, Quality Manufacturing Engineers, Product Industrialization Engineers, Supplier Quality Engineers, Reliability Engineers
• Within NPI and Sustaining Projects, supports all ongoing Project activities e.g. coordinates Quality Norm planning activities, reviews and approves design deliverables and guides the Project Team regarding open Process/Quality questions.