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Engineer I, Product Design
2 months ago
Position Summary
The Engineer I position in the Vascular Access Product Engineering group is responsible for managing the post launch life cycle for products that have been released for sale.This includes analyzing change requests and implementing a change management plan, investigating and correcting non-conforming events, including Corrective Actions and Preventative Actions, remediate design history files to conform to new regulatory requirements, and developing line additions to expand the scope of a product portfolio.The Engineer I works on projects/matters of limited complexity and is closely managed by senior engineering and managerial staff.
Essential Duties & Responsibilities
•Executes activities related to implementing design changes per change management plans and company procedures.
•Writes test protocols, assists with test method validations and executes test plans, and authors drafts test reports with guidance.
•Updates design output documents such as engineering drawings, purchasing specifications, and bill of materials under direction.
•Participates in risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and identifies and implements risk mitigation.
•Provides technical support to regulatory, sales, marketing and other functional areas as needed.
•Assists with investigations of root causes leading to non-compliance events arising from design, manufacturing, procedural or customer use.
•Works on special projects as assigned.
Knowledge & Skills
•Able to solve technical problems using basic engineering principles and analytical ability while learning the use of effective methodologies
•Able to review and interpret technical documentation such as engineering drawings and component specifications with occasional assistance from senior staff
•Able to work accurately with attention to detail
•Able to handle multiple priorities and meet key deadlines through effective time management skills and guidance
•Able to communicate professionally to technical and non-technical internal and external customers through conversations, presentations, and formal and informal electronic media
Minimum Qualifications, Education & Experience
•Must be at least 18 years of age
•Bachelor's degree from an accredited college or university is required
•0-2 years of work-related experience
•Position requires active and current compliance with all credentialing requirements, including COVID-19 vaccination, to perform the essential function of your role at customer locations.
Work Environment
•This is largely a sedentary role.
•This job operates in a professional office environment and routinely uses standard office and laboratory equipment.Work from a home office may be allowed on a limited basis.
•As part of the scope of employment, the employee must hold a valid driver's license as well as comply and meet the requirements set forth in the Authorized Driver Policy to drive on behalf of the company.
•Typically requires travel less than 5% of the time.
