Sustaining Engineer 2

Engineer 2, 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 Engineer 2, Sustaining, will typically work independently with general supervision from their team lead/mentor as necessary on moderately complex activities and projects.

- Interface 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.
- Manage 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/mentor for discussion and resolution. Utilize critical thinking and past experiences to inform project/task decisions.
- Presents project/task status updates to team members and team lead/manager. May also present to other functional leadership as necessary.
- Provides guidance and assistance to technicians or newer engineering employees/co-ops/interns/contractors. May review and approve outputs from less experienced engineers/contractors/co-ops/interns.
- Demonstrates practical/detailed design and risk knowledge of relevant product lines
- 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.

- Bachelor's degree in Engineering or Engineering Technology or related discipline and minimum 3 years of prior relevant experience. Advanced degrees may reduce the experience requirement by 1-2 years.
- Project management experience
- Familiarity with statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and demonstrated problem solving experience.
- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Engineering Server, Business Objects.