Sr Quality Engineer

Recruiter: Spencer Gregory Hale

Sr Quality Engineer

About This Role:

This Senior Quality 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

• BS in Engineering with 5-8 years of relevant experience
• 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

• Electrical, Mechanical, or Materials Engineering degree with 5-8 years of relevant experience
• 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

Requisition ID: 597350 597350 

Minimum Salary: $ 80100 

Maximum Salary: $ 152200 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.