Boston Scientific · 2 months ago
Sr. Quality Systems Engineer- Global Risk Management
US-MN-Arden Hills
Full-time
Onsite
Mid, Senior Level
$87K/yr - $164K/yr
5+ years expBoston Scientific is a global leader in medical technology, and they are seeking a Senior Quality Systems Engineer to drive and support Global Risk Management initiatives. The role involves developing and maintaining global processes and systems to meet regulatory requirements while collaborating with design teams and leading communities of practice.
Health CareMedicalMedical Device
Responsibilities
Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal and external requirements
Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process
Influencing key stakeholders through collaborative community engagement. Helping connect the key SMEs across divisions and capitalizing on networking skills to promote best practice sharing and efficient problem solving
Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
Supporting internal and external audits and audit responses for existing products
Monitoring compliance with company policies and procedures
Owning Global CAPAs, including proven experience with complex, multi-site/multi-division problem-solving
Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices
Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals
Qualification
Required
Bachelor's degree in Science, Health, or Engineering
Minimum of 5 years of Medical Device Design Controls and Risk Management experience required
Understanding of US and International regulations including 21 CFR Part 820, ISO 13485, and EN ISO 14971 is required, as well as knowledge of the Medical Device Directive and EU MDR
Preferred
Excellent oral and written communication skills (e.g., giving presentations to peer groups and various levels of management, sharing clear and concise information, managing change effectively using a variety of communication methods and tools, etc.)
Advanced project management skills (e.g., breaking projects into smaller tasks, coordinating work with other impacted process or document owners, balancing competing priorities, managing expectations on project timelines, etc.)
Expertise in Microsoft Office Suite programs including, Teams, Excel, PowerPoint, and Word
Benefits
Compensation 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 may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
H1B Sponsorship
Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
BioWorld Financial Watch
2025-12-25
2025-12-12
2025-12-11
Company data provided by crunchbase