Cook Medical

Overview

Senior Engineer, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The Senior Engineer works independently with limited supervision on complex activities and projects. The Senior Engineer acts as a mentor and leader in the department and may review/approve the work of less experienced engineers and/or contractors.

Responsibilities

• Lead discussions within team/department and with other functional personnel (Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians) as necessary to progress projects/tasks.
• Efficiently manages multiple project/task timelines, resources and responsibilities to achieve team, departmental, and company goals.
• Identify and escalate problems/obstacles and identifies possible solutions to team lead/manager for discussion and resolution. Works with other team members to provide problem-solving guidance. Utilize critical thinking and past experiences strategically to inform project/task decisions.
• Presents project/task status updates clearly to team members and team lead/manager. May also present to functional directors/executives as necessary.
• Provide guidance and assistance to technicians or newer engineering employees/co-ops/interns/contractors. Reviews and approves outputs as necessary.
• Demonstrates advanced design and risk knowledge of relevant product lines including process and regulatory details.
• Projects may include system or program level activities, providing overall guidance and leadership and delegating tasks as appropriate
• Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
• Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• 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 communication skills and ability to work in a collaborative and independent work situations and environments with

minimal supervision.

• Ability to remain calm and receptive in fast paced situations.

Qualifications

• Minimum 5 years of engineering experience in a regulated industry, preferably in a medical manufacturing environment. Advanced degrees may reduce the experience requirement by 1-2 years. Project management experience preferred.
• Bachelor's degree in Engineering or Engineering Technology or related discipline.
• Familiarity with statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and demonstrated problem solving experience.
• Experience in communication and working with a wide variety of associates.
• Experience working independently and directing others towards a common goal.
• Proficient in Microsoft Word/Excel/Project/Outlook.

Physical Requirements:

• Works under general office environment conditions.
• Utilizes close visual acuity for working with computers and equipment.
• Frequently required to sit, stand, walk, and communicate.
• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.