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.