Manufacturing Engineer I jobs in United States
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Boston Scientific · 4 hours ago

Manufacturing Engineer I

Boston Scientific is a leader in medical science committed to solving important health industry challenges. The Manufacturing Engineer plans and designs manufacturing processes, maximizing efficiency and ensuring product specifications are met.

Health CareMedicalMedical Device
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Responsibilities

Evaluate current console manufacturing practices and identify those needing improvement
Lead operations to increase production capacity and implement new efficient processes
Analyze and design sequence of operations and workflow to improve efficiency and establish methods for maximum utilization of production facilities and personnel
Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events
Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc
Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and improve productivity
Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing
Performs or manages process validations (IQ/OQ, OQ, PQ)
Troubleshoot production line issues related to yield, quality, and throughput
Leads scaling up processes from development to full scale manufacturing
Supports evaluation of NCR, CAPA, SCAR, Failure investigation and Deviation requests arising from Contract Manufacturers/Suppliers
Creates/Updates manufacturing instructions, routings, bills of materials and SOPs and performs training when required

Qualification

Lean Manufacturing MethodologySix Sigma MethodologyCAD software (SolidWorks)Risk Management (ISO 14971)ASME Y14.5 GD&TInterpersonal skillsCommunication skillsDocumentation skillsOrganizational skillsProblem-solving skills

Required

Engineering degree desired or equivalent experience in related job field
Proficient in CAD software, preferably SolidWorks
Familiarity with statistical analysis of raw data
Hands-on experience managing suppliers and/or contract manufacturers a plus
Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred
Proficient in Risk Management according to ISO 14971
Knowledge of ASME Y14.5 GD&T
Excellent interpersonal, communication, and documentation skills are required
Takes initiative and acts quickly to drive solutions

Preferred

Biomedical product or medical device development experience
Strong interpersonal, organizational and communication skills
A flexible team player, focusing on shared goals with a positive results‐oriented attitude
Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus
Proficiency in Minitab
Hands-on experience managing suppliers and/or contract manufacturers a plus

Company

Boston Scientific

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Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.

Funding

Current Stage
Public Company
Total Funding
$10.02B
2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B

Leadership Team

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Michael Mahoney
Chairman, President & CEO
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Daniel J. Brennan
Chief Financial Officer
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Company data provided by crunchbase