Quality Engineer I, Product Performance (Sterile Devices)

Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto

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

This role offers an individual the opportunity to be part of the Access Solutions Complaint Investigation Site within the Post Market Quality Assurance team at Boston Scientific. The primary activity for this role is to complete product analysis for investigations of 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:

• Completing investigations to ensure field allegations are adequately addressed in a timely manner.
• Analyzing returned products through visual inspection, geometric analysis, mechanical testing and electrical testing to address complaints and to ensure a high level of product quality.
• Monitoring product performance for the products under their ownership and works with the appropriate cross functional groups to address quality issues.
• Focusing on continuous improvement initiatives within the Post Market Quality department.
• Fostering a diverse 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.
• Assists technicians during complaint/analysis investigations to ensure accurate and compliant product analysis and documentation.
• Communicate product quality issues to Senior Engineers and/or Management for awareness to cross functional areas including Post Market Surveillance, Research and Development, Design Assurance, Supplier Quality and Manufacturing
• Adhere to all requirements of the Quality Management System.
• Demonstrate company values, work with integrity, and be a supportive team member.
• Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
• Other duties as required.

Required qualifications:

• Bachelor's Degree in Engineering
• 1+ years of relevant work experience
• Demonstrates critical thinking and problem-solving capabilities
• Strong communication skills, with the ability to collaborate and influence across multiple, cross-functional teams
• Ability to independently manage project work to define delivery dates

Preferred qualifications:

• Degree in Mechanical or Biomedical Engineering
• Understanding and working knowledge of Medical Device Quality Systems and Regulatory Requirements
• Knowledge of cardiac anatomy and electrophysiology
• Experience in the medical device industry
• Continuous improvement and Six Sigma experience

What we have to offer:

• Hybrid working model for many roles combining on-site and remote work, paired with flexible working hours.

• Comprehensive total rewards package, including bonus, RRSP or 401k employer matching, tuition reimbursement, health & dental benefits, and a health or lifestyle (your choice!) spending account.

• Generous paid time off, including vacation days, personal days, statutory holidays, and a Holiday shutdown!

• A strong commitment to mental health and well-being, including a company-paid meditation app, meditation rooms in some buildings, fully trained Mental Health First Aid staff members, and weekly yoga/HIIT/Pilates/mindfulness online professionally-led classes for all employees.

• Headquarters based roles offer functional outdoor spaces (bring your laptop to one of multiple wi-fi connected outdoor patios to work) and access to a beautiful ravine trail system for lunchtime walks

• Employer subsidized gourmet, high-quality, healthy meals available onsite, freshly delivered multiple times a week.

• Strong senior leadership commitment to Inclusion and Diversity; many opportunities to join I&D committees and spearhead I&D initiatives; employer-hosted roundtables with external experts, guest speakers and workshops/celebrations.

• Formal mentorship program, robust biweekly internal networking events and multiple communication streams open to senior management for all employees to provide continuous feedback

• Employee-friendly work environment, with opportunity to participate in employee-led clubs (for example, book club, French club, gardening club, rock climbing club, boardgame club, tea club), and support to create new clubs

• Employee recognition rewards platform (Guusto) – receive gift cards as recognition for a job well done!

• Formal leadership training programs for leaders and non-leaders to develop their careers

• Purposeful work that drives career development, with opportunities to learn and grow by way of on-site training, workshops, and lunch and learn sessions.

• Smart commute options including complimentary shuttle from Kipling Station, subsidized transit program and complimentary Electrical Vehicle charging on site.

  
  

Requisition ID: 563091

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!