Sr. Electrical Engineer
Intracept by Boston Scientific
Sr. Electrical Engineer
This Senior Electrical Engineer role offers an employee the opportunity to be part of the Cardiac Rhythm Management Complaint Investigation Site within the Post Market Quality Assurance team at Boston Scientific. The primary activity for this role is to support analysis of investigations into field complaint allegations against Boston Scientific products. This position is a vital part of improving patient care by ensuring Boston Scientific device allegations are investigated efficiently and effectively.
Your Responsibilities Will Include:
- Assumes a technical role within the Complaint Investigation Site by using technical expertise and knowledge to support current and new market released technology
- Assists junior level engineers in projects to enhance the ability to perform various complaint Investigations
- Maintains knowledge of state-of-the-art principles and strategies in their particular area of expertise.
- Participates in technical strategy planning for Boston Scientific
- Assists Lab Technicians during complaint investigations to ensure accurate and compliant product analysis and documentation
- Reviews completed returned product analysis results to ensure field allegations are adequately addressed
- Analyze returned products to address complaints and to ensure a high level of product quality
- May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources; Identifies and leads cross-functional project teams comprised of functional experts and local managers
- Communicate product quality issues to Senior Management for awareness to cross functional areas including Research and Development, Supplier Quality, and Manufacturing
- Participates in cross functional teams to resolve quality issues
- Interprets complex technical issues for a non-technical audience
- Provides technical support for regulatory and legal inquiries
- Assists in developing novel methods to effectively analyze product complaints
- Performs a variety of duties in the electrical, mechanical, electro-mechanical, chemical, or optical areas
- Supports and/or performs Product Performance Engineering activities (trending, non-product return investigation analysis, etc.) during complaint investigation processing
- Responds to Technical Service Requests to support urgent questions from the Technical Service Team regarding product performance issues of devices being utilized in the field
- Serve as a support role for other activities within in the Complaint Investigation Site as needed
What We're Looking For In You:
Minimum Qualifications
- Electrical, Mechanical, or Materials Engineering degree
- 5 or more years of relevant electrical engineering experience working within quality system processes and procedures
- Understanding and a command of highly technical engineering topics
- Ability to independently manage project work to define delivery dates
- Understanding and experience operating within the quality system processes and procedures
- Critical thinking, problem solving, and troubleshooting ability
- Strong communication (verbal and written) and data analysis skills
Preferred Qualifications
- A strong technical understanding of CRM products and device therapy
- Strong Technical Writing skills
- Strong understanding of the Quality System and experience with the post-market quality function and/or systems
- Experience interacting with Medical Safety, Design Assurance, R&D, Return Product Analysis, Supplier Development and/or Manufacturing
- Experience supporting competent authority responses
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