Fellow R&D Engineer jobs in United States
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Boston Scientific · 14 hours ago

Fellow R&D Engineer

Boston Scientific is a leader in medical science with a commitment to solving critical health challenges. They are seeking a Fellow R&D Engineer to contribute to the design and development of therapeutic medical devices, overseeing the entire development process from concept to commercialization.

Health CareMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Utilize research and experience to develop new products and processes to increase performance
Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives
Collaborate with external suppliers for component and process design and identify outsourcing opportunities
Provide technical leadership and maintain the engineering staff’s knowledge of technology and engineering areas associated with instrument and mechanism design and manufacturing processes
Understand the technology and key product features that ensure clinical and commercial success
Manage research and development activities from Concept Phase through Commercialization
Make data driven decisions using appropriate analytical methodologies
Prepare for and conduct various design reviews in accordance with product development
Demonstrate deep insight regarding design intent and uses insight to drive product requirements and specifications. Develop processes necessary to fabricate devices. Develop and implement test methods for assessing the quality of in-process and finished products
Develop, execute, and analyze design verification and validation studies, culminating in a design history file
Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.)
Provide technical leadership along with technical subject matter expertise to product development team
Conduct preclinical build operations as necessary
Initiate, define, perform and execute verification and validation activities
Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities
Perform risk analysis activities and develop product testing plans and protocols; set up and run product testing and protocols in accordance with project plans
Research and recommend vendors and material choices for product
Identify hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis
Comply and analyze data, identify causes, draw conclusions, generate reports
Create and manage a schedule of technical deliverables in coordination with a project manager
Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders

Qualification

Materials ScienceMechanical EngineeringMedical Device EngineeringCAD SoftwarePolymer KnowledgeProduct TestingQuality SystemsStatistical AnalysisRisk ManagementLeadership SkillsCommunication SkillsProject ManagementCross-Functional Collaboration

Required

MS/PhD degree in Materials Science, or Mechanical Engineering w/emphasis on materials engineering preferred. BS in one of those fields will be considered but will be weighed heavily on work experience
Minimum of 10 years of experience in medical device engineering
Polymer knowledge along with extrusion, injection molding experience and metallurgy
Knowledge of and exposure to product testing and data collection
Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
Working knowledge of mechanical design principles and FDA class 3 regulated medical device design controls
Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred. This includes experience with medical device materials 7+ years product development, preferably in medical device industry
Proficient in CAD software, preferably SolidWorks
Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred
Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and computer-aided design (CAD)
Track record of strong cross-functional collaboration, influence without authority, and project management enabling highly effective project teams

Preferred

Excellent hands-on mechanical prototyping, verification, and failure analysis skills
Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results
Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA)
Strong leadership skills and mentoring capabilities
Strong quantitative analysis and problem-solving skills and methodologies
A flexible team player, focusing on shared goals with a positive results‐oriented attitude
Proficient in Risk Management according to ISO 14971
Knowledge of ASME Y14.5 GD&T
Strong interpersonal and communication skills (oral/presentation and written)

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.

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 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