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 with
minimal 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
Sr. Global Sustaining Engineer • Bloomington, IN, US
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