Project 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 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.

SummaryOf Position:
A Senior Research Engineer for the DVT Preventionbusiness will substantially contribute to the design and development andsustaining engineering activities of Intermittent pneumatic compression devicesused to prevent Deep Vein Thrombosis, a leading cause of morbidity inhospitals. These activities will cover all phases of the product life cyclefrom concept through end of life. The individual in this position will becalled upon to work in a dynamic team environment lead projects, contribute todesign decisions and execute requirements across a wide variety of projects.The devices are electro-mechanical pneumatic systems that control the inflationof pneumatic compression garments used in the prevention of Deep VeinThrombosis (DVT). The ability to execute hardware electronic designs withembedded software is a key requirement. Attention to detail and workingknowledge of regulations for the medical device industry are essential. Theengineer must be able to work in a team environment and be able to communicateclearly across all disciplines including Quality Assurance, Regulatory Affairs,Manufacturing, Marketing, Clinical Affairs and outside design partners andregulatory agencies.

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## Qualifications

Essential Functions:
• Contribute to the development and maintenance of DVT prevention systems.
• Write and review requirements specifications relating to both electronics and software.
• Critically evaluate hardware and software design implementations and challenge and confirm design decisions for optimal project outcomes.
• Conduct technical and design reviews.
• Write protocols and reports for various technical aspects including, but not limited to design verifications and validations
• Conduct product development tasks & documentation required to satisfy design controls and risk management in accordance with established SOPs.
• Provide presentations, reports and schedules as required to manage projects and to communicate status, risks and issues.
• Effectively and thoughtfully incorporate required regulatory medical device standards (FDA, ISO, IEC, EN)
• Interface with Program Management to provide schedule input
• Construct Design History Files in accordance with SOP’s.
• Obtain and maintain safety certifications to medical device standards through organizations such as UL, Intertek, TUV
• Drive the development of solutions to technical issues and implement within the established design and design change control processes.
• Lead and influence offsite and 3rd party design engineering resources.
Minimum Requirements:
Education: BS, Electrical Engineering or Biomedical engineering with electrical engineering concentration
Minimum Experience:
Bachelor’s plus a minimum of 5 years relevant medical device experience; or Master’s plus a minimum of 3 years relevant medical experience;
Skills/Qualifications:
• PCB design software such as PCAD, PADS OrCAD or Altium
• Familiarity with electrical and medical device safety standards
• Requirements development and management for embedded systems
• Knowledge of Good Manufacturing Practices (GMP), Quality System Regulations (FDA QSR) and design controls
• Requirements Tracing
• Design for Six Sigma techniques and methodologies and knowledge of Statistical Analysis, and Design of Experiments. Working knowledge of Minitab or equivalent statistical analysis tools
• Strong written, verbal, and presentation skills
• MS office tools including Word, Excel, PowerPoint, Project
• Thorough understanding of engineering practices, product safety and

## Additional Information

To know more about this position or to schedule an interview, please contact

Sagar Rathore

sagar.rathore(@)collabera.com