Project Engineer

Collabera; Mansfield (MA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Paid vacation

Medical insurance

Dental and vision insurance

401K retirement savings plan

Life insurance

Disability insurance

Job summary

An established IT staffing firm is seeking a Senior Research Engineer to contribute to the design and development of medical devices preventing Deep Vein Thrombosis. Candidates should possess a BS in Electrical or Biomedical Engineering and ideally have over 5 years of experience in medical device development. Critical skills include PCB design and familiarity with regulatory standards. The role involves working in a collaborative team environment, engaging in hardware design, and managing compliance with safety certifications and protocols.

Qualifications

• Minimum of 5 years medical device experience for Bachelor’s or 3 years for Master’s.
• Strong understanding of design controls and regulatory standards.
• Ability to execute hardware electronic designs with embedded software.

Responsibilities

• Contribute to the development of DVT prevention systems.
• Write and review specifications for both electronics and software.
• Conduct product development tasks and manage design controls.

Skills

PCB design software

Familiarity with electrical and medical device safety standards

Requirements development

Knowledge of GMP and Quality System Regulations

Design for Six Sigma

Statistical Analysis

MS Office tools

Strong written and verbal skills

Education

BS in Electrical Engineering or Biomedical Engineering

Tools

PCAD

PADS

OrCAD

Altium

Minitab

Job description

Overview

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.

Job Description

Summary Of Position: A Senior Research Engineer for the DVT Prevention business will substantially contribute to the design and development and sustaining engineering activities of Intermittent pneumatic compression devices used to prevent Deep Vein Thrombosis, a leading cause of morbidity in hospitals. These activities will cover all phases of the product life cycle from concept through end of life. The individual in this position will be called upon to work in a dynamic team environment lead projects, contribute to design decisions and execute requirements across a wide variety of projects. The devices are electro-mechanical pneumatic systems that control the inflation of pneumatic compression garments used in the prevention of Deep Vein Thrombosis (DVT). The ability to execute hardware electronic designs with embedded software is a key requirement. Attention to detail and working knowledge of regulations for the medical device industry are essential. The engineer must be able to work in a team environment and be able to communicate clearly across all disciplines including Quality Assurance, Regulatory Affairs, Manufacturing, Marketing, Clinical Affairs and outside design partners and regulatory agencies. rootcause analysis

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 SOPs.
• 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 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