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 bolthires estimates for customers Can support prototype development to meet regulations, test products for safety and adjust them to meet engineering codes and safety standards.
What We're Looking For
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 Preferred Candidates 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 a world leader in the $250 billion Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all. Learn more about and. 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 is a drug-free workplace. As a condition of employment, all hires are required to pass a pre-employment drug test. 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, sexua Apply tot his job Apply To this Job