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Product Support Engineer 2
2 months ago
The Product Support Engineer 2 will engage in activities focused on the maintenance and enhancement of commercially available medical devices. Responsibilities may include product improvement initiatives, risk evaluations, assistance with compliance processes, and enhancements to existing products and processes. This role typically functions independently while receiving general guidance from a team lead or mentor on complex projects.
Key Responsibilities- Collaborate effectively within the team and across various departments, including Production Engineering, Product Management, Regulatory Affairs, Clinical, Quality Engineering, Quality Assurance, Operations, and external partners, to drive project progress.
- Manage multiple project timelines, resources, and responsibilities to achieve departmental and organizational goals.
- Identify and escalate challenges, proposing viable solutions for discussion and resolution with the team lead or mentor. Utilize analytical skills and prior experiences to inform project decisions.
- Provide updates on project progress to team members and leadership, and may present findings to other functional leaders as necessary.
- Mentor and support junior engineers, technicians, interns, and contractors, and may evaluate and approve their work outputs.
- Exhibit a thorough understanding of design and risk management related to relevant product lines.
- Comply with Risk Management protocols and adhere to ISO 14971 standards as applicable.
- Follow Design Control procedures and meet the requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.
- Fulfill all training requirements for the position and actively pursue opportunities for professional growth and development.
A Bachelor's degree in Engineering or a related field, along with a minimum of 3 years of relevant experience. Advanced degrees may reduce the experience requirement by 1-2 years.
- Demonstrated experience in project management.
- Knowledge of statistical methods related to sample sizes, confidence intervals, capability analysis, risk assessment, and proven problem-solving skills.
- Proficiency in Microsoft Office Suite (Word, Excel, Project, Outlook), JBase, Engineering Server, and Business Objects.
