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Senior Engineer, Sustaining
1 month ago
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 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/Work Environment:
- 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.
Work Authorization Requirements:
**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**
