Desgin Quality Engineer

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.

Collabera recognizes the true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

Job Description

Work with a senior design quality engineer to oversee the quality of a number of products in the Health Informatics and Monitoring product line.

1. Create risk management plans, perform product risk assessment, facilitate the failure mode effects analysis, and create final risk management reports.
2. Promote a structured software development process. Assure that control is maintained for in-house and outsourced software development.
3. Ensure compliance with internal and external procedures and regulations.
4. Participate in review of requirements, architecture, design, code and other work products with a focus on patient safety and device quality, testability, manufacturability and serviceability.
5. Participate in change review meetings for product and non-product software.
6. Provide oversight of product software verification and manufacturing software validation processes.
7. Generate metrics for assessing software quality and evaluate results.
8. Contribute to process improvements by developing and/or updating written company or departmental procedures related to software development.
9. Provide oversight during software release to manufacturing as well as internal distribution.
10. Administer and control problem-tracking database and oversee defect process resolution.
11. Support outsourced software vendor audits and qualification.
12. Ensure that new product development and changes to existing products are conducted in compliance with the FDA Quality System Regulations and Medtronic internal processes.
13. Provide guidance and direction for sample size and statistical analysis of verification and validation test results.
14. Provide training to project teams on procedures, statistical methods and design controls.
15. Review Design History Files and Technical Files for conformance to applicable requirements.
16. Assist, when appropriate, with internal and supplier audits.
17. Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.

Qualifications

Required:

1. Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
2. Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and knowledge of how these are applied in the software development lifecycle.
3. Experience in SDLC software development techniques and IEC 62304 requirements, versed in guidance documents such as TIR-45, IEC TR 80002-1 and Cybersecurity guidance from FDA.
4. Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products.
5. Experience in risk evaluation techniques, such as Product Risk Assessment and FMEA including software risk assessment and software FMEA.
6. Familiar with reliability analysis and test methods, including software reliability modeling.
7. Working knowledge of C and C++.
8. Good verbal (including presentation) and written communication skills.
9. Ability to effectively work on project teams.

Preferred:

1. Understanding of Object Oriented programming techniques.
2. Working knowledge of C#.
3. Working knowledge of Unified Modeling Language (UML).
4. Bachelor of Science degree in Software Engineering, Computer Science, Computer Engineering or Electrical Engineering.

Additional Information

To get further details or to schedule an interview please contact: