Boston Scientific · 1 day ago
Senior Quality Engineer - Combination Device
Arden Hills, MN
Full-time
Onsite
Mid, Senior Level
$83K/yr - $157K/yr
5+ years expBoston Scientific is a leader in medical science committed to solving the most important health industry challenges. The Senior Quality Engineer will provide Process/Quality Engineering support to the manufacturing of combination medical devices, ensuring the delivery of the highest quality products to customers and supporting product development teams.
Medical DeviceHealthcareHealth CareMedical
No H1B
Responsibilities
Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for implementing product stops & documenting release criteria
Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members. May be responsible for risk analyses and FMEAs
Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects
Collects and analyzes Leads Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams
Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned
Responsible for sustaining compliance and continuous improvement related to the manufacture of combination medical devices per 21 CFR part 4. Serve as technical lead in audits related to 21 CFR part 4 compliance
Responsible for performing appropriate analysis to identify trends, improvement opportunities, and/or corrective actions related to combination medical devices per 21 CFR Part 4
Responsible for the final Process Monitor Release for products prior to distribution
Qualification
Required
Bachelor's degree in chemical engineering, chemistry or related field
Minimum of 5 years of relevant manufacturing experience
Regulated industry experience
Knowledge and ability to use statistical methods such as trend analysis, pareto and other charting techniques
Preferred
7+ years relevant experience with 2 of those years as technical leadership experience
Strong verbal, written communication skills, both technical and conversational
Decision making and negotiation skills, individually and within groups
Experience in managing multiple projects across multiple organizational disciplines
Experience in 21 CFR Part 4, cGMP compliance for drug combination medical devices
Audit experience as a technical lead
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
Funding
Current Stage
Public CompanyTotal Funding
$10.01B2025-02-21Post Ipo Debt· $1.57B
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
Medical Device Network
2026-02-10
2026-02-09
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