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 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.
Work with a senior design quality engineer to oversee the quality of a number of products in the Health Informatics and Monitoring product line.
• Create risk management plans, perform product risk assessment, facilitate the failure mode effects analysis, and create final risk management reports.
• Promote a structured software development process. Assure that control is maintained for in-house and outsourced software development.
• Ensure compliance with internal and external procedures and regulations.
• 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.
• Participate in change review meetings for product and non-product software.
• Provide oversight of product software verification and manufacturing software validation processes.
• Generate metrics for assessing software quality and evaluate results.
• Contribute to process improvements by developing and/or updating written company or departmental procedures related to software development.
• Provide oversight during software release to manufacturing as well internal distribution.
• Administer and control problem-tracking database and oversee defect process resolution.
• Support outsourced software vendor audits and qualification.
• Ensure that new product development and changes to existing products are conducted in compliance with the FDA Quality System Regulations and Medtronic internal processes.
• Provide guidance and direction for sample size and statistical analysis of verification and validation test results.
• Provide training to project teams on procedures, statistical methods and design controls.
• Review Design History Files and Technical Files for conformance to applicable requirements
• Assist, when appropriate with internal and supplier audits.
• Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues
QualificationsRequired:
• Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
• 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
• 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
• 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
• Experience in risk evaluation techniques, such as Product Risk Assessment and FMEA including software risk assessment and software FMEA
• Familiar with reliability analysis and test methods, including software reliability modeling
• Working knowledge of C and C++
• Good verbal (including presentation) and written communication skills
• Ability to effectively work on project teams.
Preferred:
• Understanding of Object Oriented programming techniques
• Working knowledge of C#
• Working knowledge of Unified Model Language (UML)
• ASQ CQE, CRE or CSQE certification
• Bachelor of Science degree in Software Engineering, Computer Science, Computer Engineering or Electrical Engineering
Additional InformationTo get further details or to schedule an interview please contact:
Sagar Rathore
630-485-2166
sagar.rathore(at)collabera.com
Skills Required
- Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
- Skilled in product risk assessment, requirements management, and defect tracking
- Experience in SDLC software development techniques and IEC 62304 requirements
- Good verbal and written communication skills
- Working knowledge of C and C++
Collabera Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Collabera and has not been reviewed or approved by Collabera.
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Fair & Transparent Compensation — Pay is considered acceptable to strong on select technical contracts and in certain geographies, with some assignments described as substantially above typical consultant rates. Outcomes appear closely aligned to client budgets and market conditions, delivering solid value in higher‑demand niches.
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Career-Linked Recognition & Rewards — Compensation tends to track niche skills and client demand, leading to more favorable pay for specialized technical roles and markets. This structure helps some cohorts perceive their pay as market‑competitive.
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Wellbeing & Lifestyle Benefits — Offerings include access to mental‑health therapy sessions and gym membership or reimbursement. These additions complement core coverage in some roles.
Collabera Insights
What We Do
In our relentless pursuit of greatness, we are dedicated to developing individuals, creating exceptional teams, and cultivating a unique culture of unity and care. As providers of digital talent solutions, we aim to positively impact businesses and communities globally. We would be honored to be your trusted and uncommon partner on this journey.
