Risevoic
Sr. Global Sustaining Engineer
Company : Cook Medical
Location : Bloomington, IN, 47404
Job Type : Full Time
Date Posted : 2 January 2026
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. This is a Global Sustaining Engineering position.
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 withminimal supervision.- Ability to remain calm and receptive in fast paced situations.
Qualifications
- Minimum 5 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.- 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
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Frequently asked questions
A Global Sustaining Engineer typically advances by deepening expertise in product lifecycle management, regulatory compliance, and cross-functional leadership. In medical manufacturing, this role increasingly demands strategic problem-solving and mentoring skills, reflecting a shift from technical tasks to broader project and team oversight.
Mastery of risk analysis, regulatory frameworks like ISO 13485, and proficiency with tools such as Microsoft Project are vital. Additionally, strong communication and project management capabilities enable effective collaboration across global teams and ensure sustained product quality.
Certifications in quality management systems (e.g., Six Sigma, ISO standards) and project management (PMP) can enhance credibility. Experience in regulated industries, especially medical devices, is highly regarded and may offset formal education requirements.
Bloomington's medical manufacturing sector shows steady growth, with moderate competition for sustaining engineer roles. Candidates with multi-disciplinary experience and strong regulatory knowledge tend to stand out amid local hiring preferences.
Bloomington offers manageable commute times with several residential areas near Cook Medical. Efficient transit options and local amenities contribute positively, helping engineers maintain a balanced routine despite project-driven workloads.
Cook Medical fosters leadership through mentorship opportunities, cross-departmental collaboration, and continuous learning initiatives. Senior engineers are often entrusted with guiding less experienced colleagues while steering complex projects that align with company goals.
This position uniquely blends global project oversight with direct regulatory and quality assurance involvement. Cook Medical emphasizes innovation in sustaining commercially available products, offering engineers a dynamic environment with impactful cross-functional interactions.
Salaries for senior sustaining engineers in Bloomington generally range from $95,000 to $125,000 annually, depending on experience and education. This range reflects the specialized skills required in regulated medical manufacturing and leadership responsibilities.
Compliance with ISO 14971 and 21 CFR 820 ensures that product risks are systematically managed and quality standards are met. For sustaining engineers, this knowledge is essential to maintain product safety and regulatory approval throughout the product lifecycle.