Quality Engineer I

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the role:

Responsible for providing technical acumen and leadership to the Arden Hills Post Market Complaint Investigation Site (CIS) that directly supports complaint product investigations and signal escalations ranging from Single Use Devices to Capital Equipment and accessories within the Electrophysiology (EP) division. The team uses product performance data to investigate post-market field performance signals in collaboration withother Post Market functions, R&D,Design Assurance, Operations, Supplier Management, and Medical Safety. Key focus is on understanding and developing product and process specific improvements to increase rate of actionable outcomes of product investigations and improved use of Engineering Essentials and Problem-Solving Analytics to improve product performance in sustaining and future product lines. This person will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level, and isresponsible for identifying and implementing continuous improvements to improve product performance and complaint processes. This role provides significant visibility across site and divisional leadership.

Work Mode:
At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model, requiring employees to be in our local office at five days per week.

Relocation:
Relocation assistance is not available for this position at this time.

VISA:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• Analyzing customer complaints, events, and other post market surveillance data by examining the data for patterns and trends and investigating when necessary.
• Conducting product signal escalation analysis, investigation, and quality system documentation to identify performance improvement opportunities. May include NCEP & CAPA ownership.
• Mentoring product investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques. Grow team utilization of investigative equipment (X-Ray, FTIR, SEM, etc.)
• Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements.
• Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required qualifications:

• Bachelor's degree in engineering or other related technical/scientific discipline
• Experience in Medical Device industry or a Quality organization

Preferred Qualifications

• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards
• Experience supporting and performing complaint investigations for Electrophysiology medical devices
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Ability to collaborate and influence across multiple, cross-functional teams
• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-starter with the ability to identify improvement opportunities

Requisition ID:624814

Minimum Salary:$59900

Maximum Salary: $113800

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 transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more atwww.bostonscientific.comand follow us onLinkedIn.

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 identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specificprohibited substancetest 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.