Immediate need for a talented Product Design Engineer (Medical Devices) . This is a 06+ Months Contract opportunity with long-term potential and is located in Skaneateles, NY(Onsite) .
Please review the job description below and contact me ASAP if you are interested.
Job ID : 24-30325
Pay Range : $60 / hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities :
- 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.
Key Requirements and Technology Experience :
- 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.
Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions.
If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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