Data Analysis Engineer II at Boston Scientific Corporation Malaysia

, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

10 Feb, 26

Salary

0.0

Posted On

12 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Analysis, Data Visualization, Statistical Analysis, SQL, Excel, Python, R, Quality Assurance, Regulatory Compliance, Problem Solving, Collaboration, Communication, Medical Device Industry, ISO Standards, CAPA, PMS Data

Industry

Medical Equipment Manufacturing

Description

Monitor complaint‑reduction initiatives, maintain trackers, and publish regular updates to stakeholders. Analyze complaint and post‑market data to identify signals, trends, and outliers; quantify impact and recommend actions. Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Link field data insights to risk management deliverables and sustaining DQA activities (e.g., CAPA inputs, PIRs, field signal evaluations). Build, maintain, and improve departmental dashboards and recurring management reports. Ensure data integrity across sources; automate reporting where feasible. Create clear data visualizations and executive‑ready narratives for decision‑making. Coordinate updates, action logs, and timelines for complaint‑reduction projects across multiple functions. Support effective quality assurance, process controls, and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products. Support internal and external regulatory audits as required. Champion compliance with company policies, SOPs, and quality system requirements. Apply structured problem‑solving methodologies (5 Whys, Is‑Is Not, DMAIC) to investigate and resolve issues. Bachelor's degree in engineering (Industrial, Biomedical, Mechanical, Systems), Data Science/Analytics, Computer Science, or related field. Minimum 2 years of experience in data analysis, preferably in medical device or regulated industries. Proficiency with data visualization and reporting tools (Power BI or equivalent); advanced Excel. Working knowledge of SQL and statistical analysis software (Minitab or equivalent). Ability to analyze complex datasets, detect trends, and communicate actionable insights. Strong collaboration and coordination skills to manage updates and timelines across stakeholders. Excellent written and verbal communication skills. English advanced Experience with PMS/complaint data and quality metrics. Familiarity with ISO 13485, ISO 14971, 21 CFR 803/820, and EU MDR vigilance requirements. Scripting in Python or R for analysis/automation. Six Sigma Certification

Responsibilities

The Data Analysis Engineer II will monitor complaint-reduction initiatives and analyze complaint and post-market data to identify trends and recommend actions. They will also build and maintain dashboards, ensure data integrity, and support quality assurance processes.