Project Engineer

US-CA-Fremont
Job ID
2017-7591
# of Openings
1
Job Category
Engineering

Overview

Contribute to a Safer, More Secure, and More Sustainable World 

 

#ThisIsOurNormal

 

At UL, we know why we come to work. Thousands of us around the world wake up every day with one common purpose – to make the world a safer, more secure, and more sustainable place to live. We clear the way for our customers to introduce the latest products, technological advances, and systems in an increasingly complex world so they can provide peace of mind to the market. Our integrity is woven throughout our company and shapes the way we approach and deliver our solutions. We are proud that the work we do every day has a meaningful contribution to society. We continue to build upon our legacy of trusted expertise and partnership to keep our communities safe and secure as we march forward into the future. This helps us to sleep better at night, and we are confident that the millions of people we touch rest easier too.

 

Take the next step in your career with our global Consumer Life & Health Regulatory team at UL. Every day we push boundaries, provide peace of mind, and unlock what's next. This is our normal. In addition, we provide excellent benefits including bonuses, paid volunteer days and 401k match.

Responsibilities

Medical Devices are some of the most regulated products in the world. In this role, you will be a part of the UL Medical Regulatory Team. Working with limited supervision, you will independently assist and support auditing and processing of manufacturer submissions to the ISO13485, the Medical Device Singe Audit program, Medical Device Directive (MDD) or the In Vitro Diagnostic Directive (IVDD) and, where applicable, other regulatory requirements. Within the framework of our Regulatory Services you will:.

  • Identify and manage priorities as demonstrated by the ability to establish, track, and meet schedules for multiple projects while maintaining project quality
  • Have a strong customer focus, flexibility
  • Demonstrate a confident, calm and decisive personality
  • Perform audits at the customer site lasting anywhere from 2 to 10 business days.
  • Perform contract review / project planning for technical file/design dossier evaluations and quality management system audits.
  • Assess technical file/design dossier and quality management systems against European Directives, essential requirements and latest common technical specifications.
  • Support regular quality system and technical audits, including unannounced audits.
  • Subject to training and qualification milestones, perform key CE certification responsibilities to support safe products to market.
  • Perform key development and support of UL’s Medical Device processes for future CE Regulations;
  • Participate in development and delivery of training materials to UL assessors.
  • Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
  • Provide guidance and support to customers as required. Participate in client training and customer forums.
  • Overseas travel is required

Qualifications

The successful candidate will posess:

  • A degree in Microbiology, Biochemistry, Electrical or Mechanical Engineering or equivalent experience
  • Be a registered (IRCA and/or RABQSA) Quality and/or Environmental and/or Occupational Health & Safety Lead Auditor is preferred.
  • Have satisfactorily completed an RABQSA or IRCA approved training course in Quality and/or Environmental and/or Occupational Health & Safety System operation and auditing. The course(s) must include an examination, which must be passed to evidence satisfactory completion.
  • Have competent working knowledge of ISO 13485 and relevant medical device directive (MDD) and invitro diagnostic devices directive (IVDD). Knowledge of Brazilian INMETRO requirements is beneficial.
  • Be academically qualified in a recognized scientific/technological discipline.
  • Have had a minimum of five years recent and relevant industrial or business experience, of which at least three years have been devoted to the practical application of quality assurance and/or medical or in vitro dialogistic devices.
  • Ability to travel, including a valid passport and driver’s license.

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