Engineer III - 1 Shift - Onsite at Viva USA Inc.
Skaneateles Falls, NY 13153
About the Job
Title: Engineer III - 1 Shift - Onsite
Mandatory skills:
Design Compliance, medical device,
Compliance Engineering, Notified Bodies,
hospital electrical, medical gas, lEC,
compliant products, electrical, mechanical, software, technical review,
compliance strategies, compliance issues, compliance reports,
product technical files, production, product development, design standards, design codes.
Description:
Codes & Standards Engineer
SUMMARY:
Work with NPD and Sustaining teams to realize compliant products based on national and international codes. Determine applicable standards and interpret them for new and current products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Other duties may be assigned:
Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software.
Define compliance strategies to certify and list products.
Provide technical review of product to ensure alignment with national and international codes.
Help maintain and sustain the product technical files for the production life of the products.
Assist product development teams in applying and understanding design standards and codes.
Submit required compliance reports to safety agencies and review 3rd party technical files and documentation.
Review user documentation to ensure that required warnings, labels and symbols are properly
documented as required by standards.
Experience working in a regulated industry.
Experience working in the codes and standards capacity at a Medical Device manufacturer, or hospital electrical and medical gas supplier.
Demonstrated ability to assess the application of Codes & Standards to new product designs in order to obtain & maintain the agency certifications specified by the design requirements (e.g. UL, lEC, VDE, CSA).
Knowledge of lEC based safety standards, preferred: IEC/EN/UL 60601-1, lEC 60601-11, ISO10535 and EN 60601-2-52
Detailed knowledge of 60601-1-2 preferred
Qualifications
EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
BS Degree in Electrical or Mechanical Engineering or equivalent experience.
Previous Design Compliance Experience.
Minimum of 5 years' experience in the medical device industry.
Minimum of 5 years' experience in Compliance Engineering equivalent in working with Notified Bodies and standards preferred.
Excellent written and oral communication skills.
Self-motivated with high performance standards.
Note:
Shift 1st Shift
VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at hr@viva-it.com for any complaints, comments and suggestions.
Contact Details :
Account co-ordinator: Godwin Deepak A, Phone No: (847) 607-1014 Extn : 359, Email: staffing10@viva-it.com
VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008
staffing10@viva-it.com | http://www.viva-it.com
Mandatory skills:
Design Compliance, medical device,
Compliance Engineering, Notified Bodies,
hospital electrical, medical gas, lEC,
compliant products, electrical, mechanical, software, technical review,
compliance strategies, compliance issues, compliance reports,
product technical files, production, product development, design standards, design codes.
Description:
Codes & Standards Engineer
SUMMARY:
Work with NPD and Sustaining teams to realize compliant products based on national and international codes. Determine applicable standards and interpret them for new and current products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Other duties may be assigned:
Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software.
Define compliance strategies to certify and list products.
Provide technical review of product to ensure alignment with national and international codes.
Help maintain and sustain the product technical files for the production life of the products.
Assist product development teams in applying and understanding design standards and codes.
Submit required compliance reports to safety agencies and review 3rd party technical files and documentation.
Review user documentation to ensure that required warnings, labels and symbols are properly
documented as required by standards.
Experience working in a regulated industry.
Experience working in the codes and standards capacity at a Medical Device manufacturer, or hospital electrical and medical gas supplier.
Demonstrated ability to assess the application of Codes & Standards to new product designs in order to obtain & maintain the agency certifications specified by the design requirements (e.g. UL, lEC, VDE, CSA).
Knowledge of lEC based safety standards, preferred: IEC/EN/UL 60601-1, lEC 60601-11, ISO10535 and EN 60601-2-52
Detailed knowledge of 60601-1-2 preferred
Qualifications
EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
BS Degree in Electrical or Mechanical Engineering or equivalent experience.
Previous Design Compliance Experience.
Minimum of 5 years' experience in the medical device industry.
Minimum of 5 years' experience in Compliance Engineering equivalent in working with Notified Bodies and standards preferred.
Excellent written and oral communication skills.
Self-motivated with high performance standards.
Note:
Shift 1st Shift
VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at hr@viva-it.com for any complaints, comments and suggestions.
Contact Details :
Account co-ordinator: Godwin Deepak A, Phone No: (847) 607-1014 Extn : 359, Email: staffing10@viva-it.com
VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008
staffing10@viva-it.com | http://www.viva-it.com
Salary
51 - 56 /hour