Software Development Life Cycle Analyst
We are looking for a self-motivated subcontractor who will assist in the remediation of a client Software Development Life Cycle (SDLC) Program. This position requires performing Gap Assessment, Risk Management and Technical writing of Standard Operating Procedures (SOP's) and templates. All procedures must be written according to compliance with 21 CFR Part 820.30, IEC62304:2008 and TIR45. Candidate must have experience writing procedures per Medical Device Regulations.
Responsible for the following activities with minimal supervision:
- Authorship of Software Development Life Cycle SOPs, work instructions and templates for regulated software in accordance with regulatory requirements and client business practices and procedures
- Ensure SDLC is in compliance with internal guidelines and SOPs
- Use Standards, Regulations, and FDA Guidance documents and show the relationship to the SDLC
- Collaborate with current software development contributors to the SDLC process
- Participate on and may lead various cross-functional teams involving interaction with client staff
- Act as a mentor to client staff
- Oversee all activities or responsibilities and ensure quality and accuracy of deliverables, and ensure deadlines are met appropriately
- Creation of training materials
- Oversee or manage communication with partner companies and collaborative sponsors
- Takes lead for particular projects and is fully responsible for all activities relating to them
- Liaises with various internal and external groups to maintain a high level of quality and consistency across functional teams on best practices and industry standards
- Participate in process improvement and educational initiative
Skills and Qualifications
Bachelor's Degree in Software Development, Computer Science, equivalent degree or equivalent experience
10+ years' experience in Software Development or Management
5+ years' experience in writing and maintaining SOPs, WINs, and software project documents
Must be well versed in 21CFR Part 820.30, IEC62304 and TIR45. Understands current regulations in Medical Device Software.
Must be proficient in written and verbal communication.
Demonstrates attention to details, teamwork and initiative
Technical experience with developing software in a regulated environment
Knowledge of computer systems, data processing, and enterprise software applications.
Demonstrates ability to mentor and coach
Good working knowledge skills with Microsoft Office Products, Microsoft Visio, and Microsoft Project
Works independently, establishing work priorities and direction
Ability to follow guidelines and procedural documents
The ability to present a clear picture of complex issues
Ability to effectively represent Software Development on multidisciplinary teams
Ability to evaluate and analyze procedural gaps
Excellent project management skills with the ability to align internal and external resources
Ability to react constructively in a high-energy and fast paced environment
Candidate will be willing to be a 1099 Sub-contractor
This position may require 30+ hours per week of fulfilling employment
SDED Global works with companies that need to be FDA compliant. We provide solutions in Audits, Compliance, Software Development, Training and Validation, We accomplish this by working with client systems and remediation for any components that may be at risk. Our experts take a risk-based approach, doing what's right to ensure our clients are compliant by making certain they understand what needs to be accomplished. Our growing business has over 23 years of experience in excellence.
No man, woman or child should EVER suffer as a result of an adulterated or failed medical device. At SDED Global, it is our passion to ensure that this statement is fulfilled. SDED Global is a Medical Device Compliance Consulting firm that drives clients to excellence ensuring safe and effective medical devices domestically and internationally.
The CEO has worked in the medical device industry for 24+ years. Her education in biochemistry, began at the bench in Research/Development and led to experience in many areas of the industry from Quality to Software Development and Validation. She became integrated in what it took to confirm that a product adhered to the standards and regulations for various submissions. She thrived in this area. It is not only the goal of SDED Global, but her personal mantra, to not only adhere to but surpass global regulations and standards.
At SDED Global, we evaluate Client needs and customize the required strategy and solution to provide high Quality Compliance Consulting that is Efficient, Innovative, Analytical, Deliverable and first to market. We offer the best customer experience and empower our clients with skill sets to maintain a defend-able product. We not only meet their immediate needs
South San Francisco, CA
Fri, 28 Apr 2017 11:25:05 PDT