Want Senior Engineering Consultant - Medical Devices (Remote) in USA
Job title: Senior Engineering Consultant - Medical Devices (Remote)
Company: Intertek
Job description: Job Description:
Intertek, a leading provider of ATIC (Assurance, Testing, Inspection, and Certification) Services, is looking for a Senior Engineering Consultant to join our Electrical team.
Position Overview
The Senior Consulting Engineer offers independent advice and support on Regulatory/ Safety requirements, science and/or other related topics to companies and service organizations. Analyze customer needs, capacity, and recommend design modifications if needed to meet safety requirements. The Consulting Engineer assists in providing efficient services to clients, and independently conducts on and offsite evaluation to customer specific requirements.
Scope of Work
- Research, read, and determine applicability of national codes, regulations and standards
- Read and understand schematics and manufacturing instructions. Supports development process and validates IFUs.
- Verify and validate the project scope and sample applicability. Performs pretesting and validates the results based on the scope of the project, identify required testing, and develop test plans
- Identify and document simple redesign /corrections as needed
- Conduct thorough product design reviews, and document results
- Supply information for quotes such as detailed scope, length of project, resources, samples required, and standards that will be used and apply
- Provide more specialized "expertise" in seral product categories, is subject matter expert or obtain and maintain advanced product knowledge
- Coordinate and lead client meetings/discussions
- Communicate project status to client, sales personnel, and management throughout project
- Drive open issues/opportunities to equitable closure
- Preparing cost estimates for customers
- Can support prototype development to meet regulations, test products for safety and adjust them to meet engineering codes and safety standards.
- Bachelor's degree in Engineering
- 7+ years directly related experience; prefer electrical, regulatory, safety, compliance experience with Medical Device exposure
- Experience in working in a regulatory and product development engineering capacity (OEM/Manufacture and/or NRTL, NB, Test house)
- Familiar with all medical device safety standards for active medical electrical equipment
- Experience with UL /CSA and IEC standard's interpretations to demonstrate NRTL, CE marking, and other regulatory compliance schemes
- Skills including Advanced knowledge in interpretation of standards such as IEC 60601-1 and the collateral and Standards furthermore ISO 14971, IEC 62304, IEC 62366,
- Recognized experience in the utilization of the RMP, RMA, HA, and FMEA
- A self-motived expert who can work with a minimum management support
- This individual needs to be highly knowledgeable about how to use computers and software.
- Effective communication with stake holders and clients, making it important that the person can make a good impression for the company.
- The person needs to be innovative and always trying to reach the best result for the customer.
- Ability to understand complex medical electrical devices and systems
- Making presentations and give training to clients
- Ability to travel approximately 25% of time
- Bachelor's degree BioMed, Electrical or Mechanical Engineering
- Master's Degree in Engineering
- Having knowledge of Laboratory and measurement equipment Safety standards is an advantage
- Demonstrated experience in leading cross-functional technical and business discussions with both internal and external clients
Intertek is committed to a safe work environment for our employees and clients. Learn more about our .
What we Have to Offer
When , you can expect salary and benefit package competitively placed within the local market, including
- Fully comprehensive benefits package; Medical, Dental, Vision, Life, and Disability
- 401(k) with company matching
- Competitive market pay
- quarterly incentive added-on
- Employee referral bonus
- Discounted prices on travel, merchandise, auto purchases
- Tuition reimbursement and much more
Intertek believes that are our strongest tool for success. We are an and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity.
For individuals with disabilities who would like to request an accommodation, or who need assistance applying, please email or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.
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About Us: Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.
About the Team: Backed by 125 years' experience, Intertek's Electrical team provides assurance, testing, inspection and certification for a variety of electric products, including appliances, consumer electronics, lighting, medical devices, information communications technology, HVACR, industrial, and energy transmission and distribution. Our dedicated professionals help ensure the quality, safety, and sustainability of electrical products used by people throughout the world.
Expected salary:
Location: USA
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