The #1 Site for IT and Engineering Jobs - search all IT and Engineering  jobs.

Principal Engineer

Job Description

Description:
Position: Principal Engineer, Product Quality Advanced Surgery
Contract to hire for the right candidate

Summary:
Engineer will be responsible for developing new products used in surgical procedures, through partnerships with R&D and other cross functional team members. Strong understanding of Quality compliance i.e. building quality into products through design control and compliance with procedures. Engineer should be able to navigate with sustaining the products in the field in compliance with the quality system and technical expertise and have had hands on experience with product development and risk management activities.

Responsibilities:
1. Ensure compliance to procedures, especially Design Control and Risk Management with respect to development of new products. Active participant in the Core Team, applying engineering knowledge to move projects forward successfully.
2. Ensure compliance to Change Control procedures to make changes to currently marketed product.
3. Act independently as QA R&D product SME with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on science & technical knowledge.
4. Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
5. Manage routine small projects without assistance. Coordinates with cross functional team to set realistic timelines and set team for success.
6. Recommend design improvements via customer feedback investigation and analysis.

Qualifications:
1) Knowledge of the basic principles in various engineering disciplines. Must have experience in product development demonstrating proficiency in Design control elements, problem solving, total quality management, statistical methods, DHF development, Risk file creation, problem analysis and resolution, materials science, design of experiments etc.
2) Must have initial training in concepts of
?Six Sigma
? quality techniques.
3) Completely proficient in relevant product development processes in compliance with FDA design control 21CFR820.3 and ISO13485
4) Good understanding of EUMDR desired; extensive cross-functional team experience, including technical and non-technical work.

Education/Experience:
BS in Engineering (discipline: Biomedical, Chemical &/or Mechanical)
At least 5-8 years of recent and relevant new medical device product development experiences, with proficiency and skills in DHF remediation and risk remediation.
Extensive medical device design controls experience.
Software: Word, Excel, Visio, PowerPoint, Outlook
Nice to haves: CAPA TW8 system experience, Trackwise8 proficiency
Good communication skills written and spoken and be able to participate in team meetings with conviction and confidence

Interview Platform: Video WebEx (2 to 3 rounds)

Intake notes:
1. At least 5-8 years of recent and relevant new medical device product development experiences, with proficiency and skills in DHF remediation and risk remediation.
2. Extensive medical device design controls experience.
3. Good communication skills written and spoken and be able to participate in team meetings with conviction and confidence
4. Software: Word, Excel, Visio, PowerPoint, Outlook 5. BS in Engineering (discipline: Biomedical, Chemical &/or Mechanical)
6. Nice to haves: CAPA TW8 system experience, Trackwise8 proficiency
7. Job Longevity
8. Local Candidates

Job Requirements

 

Job Snapshot

Location US-MA-Deerfield
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Energy, Oil & Gas, Other, Clinical & Scientific
Apply

Company Overview

Analysts

Analysts International Corporation (AIC) is an IT services firm fully dedicated to the success and satisfaction of its customers. From IT staffing to project-based solutions, AIC provides a broad range of services designed to help businesses and government agencies drive value, control costs and deliver on the promise of a more efficient and productive enterprise. Learn More

Contact Information

US-MA-Deerfield
AIC
(770) 255-7927
Snapshot
Analysts
Company:
US-MA-Deerfield
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Energy, Oil & Gas, Other, Clinical & Scientific
Store Type:

Job Description

Description:
Position: Principal Engineer, Product Quality Advanced Surgery
Contract to hire for the right candidate

Summary:
Engineer will be responsible for developing new products used in surgical procedures, through partnerships with R&D and other cross functional team members. Strong understanding of Quality compliance i.e. building quality into products through design control and compliance with procedures. Engineer should be able to navigate with sustaining the products in the field in compliance with the quality system and technical expertise and have had hands on experience with product development and risk management activities.

Responsibilities:
1. Ensure compliance to procedures, especially Design Control and Risk Management with respect to development of new products. Active participant in the Core Team, applying engineering knowledge to move projects forward successfully.
2. Ensure compliance to Change Control procedures to make changes to currently marketed product.
3. Act independently as QA R&D product SME with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on science & technical knowledge.
4. Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
5. Manage routine small projects without assistance. Coordinates with cross functional team to set realistic timelines and set team for success.
6. Recommend design improvements via customer feedback investigation and analysis.

Qualifications:
1) Knowledge of the basic principles in various engineering disciplines. Must have experience in product development demonstrating proficiency in Design control elements, problem solving, total quality management, statistical methods, DHF development, Risk file creation, problem analysis and resolution, materials science, design of experiments etc.
2) Must have initial training in concepts of
?Six Sigma
? quality techniques.
3) Completely proficient in relevant product development processes in compliance with FDA design control 21CFR820.3 and ISO13485
4) Good understanding of EUMDR desired; extensive cross-functional team experience, including technical and non-technical work.

Education/Experience:
BS in Engineering (discipline: Biomedical, Chemical &/or Mechanical)
At least 5-8 years of recent and relevant new medical device product development experiences, with proficiency and skills in DHF remediation and risk remediation.
Extensive medical device design controls experience.
Software: Word, Excel, Visio, PowerPoint, Outlook
Nice to haves: CAPA TW8 system experience, Trackwise8 proficiency
Good communication skills written and spoken and be able to participate in team meetings with conviction and confidence

Interview Platform: Video WebEx (2 to 3 rounds)

Intake notes:
1. At least 5-8 years of recent and relevant new medical device product development experiences, with proficiency and skills in DHF remediation and risk remediation.
2. Extensive medical device design controls experience.
3. Good communication skills written and spoken and be able to participate in team meetings with conviction and confidence
4. Software: Word, Excel, Visio, PowerPoint, Outlook 5. BS in Engineering (discipline: Biomedical, Chemical &/or Mechanical)
6. Nice to haves: CAPA TW8 system experience, Trackwise8 proficiency
7. Job Longevity
8. Local Candidates

Job Requirements

 
Sologig Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using sologig.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
Principal Engineer Apply now