Research and Development Engineer 2, iMRI

Overview

An Engineer 2 in the iMRI Emerging Division R&D team supports project(s) in the department tasked with solving engineering problems, as well as developing new products and processes, and leading engineering or company projects. This includes coordination with internal Cook functional partners and management of external suppliers. The individual will drive the completion of design control and risk management activities to support regulatory submissions and market clearances. Priority will be prototyping, feasibility development and testing, and developing Cook interventional radiology devices to meet identified iMRI procedural needs.

Responsibilities

Essential Job Functions/Duties:

• Provide technical input on defining project priorities and iMRI Emerging Division product goals.
• Identify and solve iMRI Emerging Division engineering project and system-level problems.
• Contribute technical/scientific expertise and direction to iMRI Emerging Division engineers and other company business functions.
• Excellent ability to develop device prototypes and conduct feasibility testing on new concepts.
• Assume responsibility for interpreting data, organizing, executing, and coordinating project activities.
• Participate in and supports large scale or multiple engineering projects with a high degree of independence, leading elements of those projects where necessary.
• Act as a mentor to other personnel in the iMRI Emerging Division.
• Provide technical and strategic input on managing company intellectual property relevant to area of work.
• Work closely with physicians and other internal and external customers to develop design solutions for clinical problems.
• Gather clinical application and procedural information, performance requirements, and user needs; perform design control requirements and risk analyses.
• Create, review, and approve documentation related to design and transfer to manufacturing.
• Coordinate cross-functionally (including with external design firms) to establish design input requirements, traceability tables, and risk and hazard analyses.
• Assure that project deliverables and tasks are technically excellent and completed in a timely fashion.
• Design and coordinate execution of design verification and product, process, and method validation activities.
• Utilize technical expertise for interpreting data, organizing, executing, and coordinating project activities.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and ethical standards.
• Must have effective oral and written communication skills
• Meet deadlines and complete administrative tasks such as expenses, training, reporting, policy acknowledgements, etc. in a timely manner.
• Attend meetings with customers to understand needs, gain feedback, and support the overall business.
• Within scope of responsibility, ensure all quality, regulatory, compliance, and product specific requirements are met.
• Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards including Cook policies.
  
  

Qualifications

Required Experience:

BS degree in engineering related field.

At least 3 years relevant engineering work experience.

Demonstrated experience leading projects or initiatives.

Experience in communication and working with a wide variety of associates.

Experience working independently and directing others towards a common goal.

Preferred Qualifications

Experience using analytical skills and problem solving.

At least 3 years of experience in R&D engineering or equivalent in the medical device industry.

Models the company standards that others are expected to follow.

Demonstrates positive and constructive behaviors that drive team cooperation in achieving

objectives.

Demonstrates excellent communication, leadership, and presentations skills.

Demonstrates the ability to think strategically.

Physical Requirements/Work Environment

Ability to travel internationally, domestically, and weekends as needed up to 30%.

Sitting for extended periods, utilizes close visual acuity for working with computers, etc.

Work under general office environmental conditions.

Other Requirements

Employee signs a non-competition and confidentiality agreements in relation to their employment with Cook. Employee acts in compliance with company policies including but not limited to, the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, Product Complaints, HIPAA regulations, and Cook Policy & Guidance on Interaction with Healthcare Professionals.