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Overview

Lead 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 Lead Engineer works independently with limited oversight and manages complex/difficult technical projects or processes that have a major impact on departmental results. The Lead Engineer acts as a mentor and leader in the department and reviews work outputs of less experienced engineers/contractors in the department, delegating work as necessary to achieve departmental goals.

Responsibilities

- Lead and influence 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 to appropriate level of management and implement possible solutions as necessary. Works with other team members to provide problem-solving guidance. Utilizes broad and deep experience strategically to inform project/task decisions.- Presents project/task status updates clearly to team members and team lead/manager. May also present to global functional leaders/executives as necessary.- Provide guidance and assistance to technicians or newer engineering employees/co-ops/interns/contractors. May review and approve outputs as necessary. Delegates appropriate tasks and follows-up on completion.- Demonstrates deep design and risk knowledge of relevant product lines including process and regulatory details. Recognized as company expert for relevant product lines.- Projects may include system or program level activities, providing overall guidance and leadership and delegating tasks as appropriate. Projects may affect multiple departments and/or global manufacturing entities.- 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 withminimal supervision.- Ability to remain calm and receptive in fast paced situations.

Qualifications

- Minimum 7 years 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, JBase, Engineering Server, Business Objects.

Physical Requirements:Works under general office environment conditions.- Utilizes close visual acuity for working with computers and equipment.- Frequently required to sit for extended periods of time, stand, walk, and communicate.- Personal protective equipment including safety glasses, lab coat and gloves may be required in some areas associated with this position.

- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

Requisition ID2025-16377

Posting Date2 months ago(4/4/2025 2:39 PM)

Job Location(s)Bloomington IN United States

Job LocationsUS-IN-Bloomington

Position TypeFull Time

CompanyCook Inc - Bloomington

CategoryEngineering