Senior Research and Development Engineer- Vascular

Posting Date 2 weeks ago(5/9/2022 2:57 PM)
Requisition ID
2022-10746
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Inc.
Category
Engineering

Overview

Align global development efforts in the Aortic Intervention new product development pipeline. Aligning design controls, V&V activities and general approaches with regional development teams as they researches clinical problems, and develops product solutions/designs. Project areas of focus may include development of aortic stent graft, and delivary systems as well as other vascular projects.

Responsibilities

• Function as a technical subject matter expert on aortic stent graft development, requirements, risk management and testing
•Create, review and approve documentation related to design and transfer
• Collaborate globally and cross-functionally (including with external firms) to establish design input requirements, traceability tables, risk and hazard
analysis.
• Lead and assist in the development and execution of product testing
• Provide guidance, coaching and training to other employees on establishment of design control elements (requirements, V&V, etc...)
• Maintain and develop the technical capabilities necessary to provide technical solutions to project needs.
• Assure that project deliverables and tasks are technically excellent and completed in a timely fashion.
• Work to influence global organization on policies, procedures and practices within job function.

• Contribute to the intellectual property of the company via invention
disclosures and patent applications
• Design and coordinate execution of design verification and product, process, and method validation 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 quantity standards
• Must have effective oral and written communication skills

Qualifications

• BS in Engineering or related (Advanced degree preferred);
• 5 years Experience in medical device development (Masters or Phd in relevant discipline would reduce experience needed)
• Experience in vascular stent development (Preferred in aortic stent graft)
• Experience using analytic skills and problem solving
• Current knowledge and application FDA 21CFR820, ISO 13485

• Preferred experience in developing effective completion of design controls and risk management documentation.

Physical Requirements:

• Personal protective equipment including safety glasses, lab coat and gloves required in many areas associated with this position
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Works under general office environmental conditions

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