Sustaining Engineering Specialist
2 weeks ago
Position Overview
The Sustaining Engineer 2 is responsible for executing tasks related to the maintenance and support of commercially available products. Key responsibilities include product/process remediation, conducting risk assessments, supporting regulatory approvals, and implementing product/process enhancements. This role typically operates independently with general oversight from a team lead or mentor on moderately complex projects.
Key Responsibilities
- Collaborate with team members and other departments (including Production Engineering, Product Management, Regulatory Affairs, Clinical, Quality Engineering, Quality Assurance, Operations, and external vendors) to advance project objectives.
- Oversee multiple project timelines, resources, and responsibilities to meet departmental and organizational goals.
- Identify and escalate challenges while proposing potential solutions for discussion with team leads or mentors.
- Provide regular updates on project status to team members and leadership, including presentations to other functional leaders as required.
- Offer guidance and support to technicians and less experienced engineering staff, including interns and contractors, and review their outputs.
- Exhibit in-depth knowledge of product lines, focusing on practical design and risk management.
- Adhere to Risk Management protocols and comply with ISO 14971 standards as applicable.
- Follow Design Control procedures in accordance with 21CFR820 Quality System Regulations and ISO 13485 standards.
- Maintain all necessary training requirements for the role while actively seeking opportunities for professional development.
Qualifications
- Bachelor's degree in Engineering or a related field, with a minimum of 3 years of relevant experience. Advanced degrees may allow for a reduction in experience requirements.
- Experience in project management.
- Familiarity with statistical methodologies related to sample sizes, confidence intervals, and risk assessment, alongside demonstrated problem-solving skills.
- Proficient in Microsoft Office Suite (Word, Excel, Project, Outlook), JBase, Engineering Server, and Business Objects.
Work Environment
Must demonstrate effective communication skills and the ability to collaborate and work independently in various environments with minimal supervision. A calm demeanor in fast-paced situations is essential.
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