Senior Sustaining Engineer - Post Market Engineering

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 withminimal 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 :

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