Principal Mechanical Engineer - medical device jobs in United States
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DeBellis Catherine & Morreale - Corporate Staffing · 4 days ago

Principal Mechanical Engineer - medical device

DeBellis Catherine & Morreale is a recruiter for a cutting-edge medical device start-up company focused on developing innovative infusion technology. They are seeking a Principal Mechanical Engineer to research, develop, and improve mechanical features for medical devices, ensuring compliance with industry standards and supporting product development efforts.

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Hiring Manager
Mike DeBellis
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Responsibilities

Think outside the box
Ideate innovative concepts for solving engineering challenges
Rapidly prove/disprove those concepts through feasibility testing, leveraging tools such as 3D printers
Write Engineering Development Plans for projects
Develop concise and intelligent Design Requirements, through collaboration with key cross functional stakeholders
Read, understand, and design in compliance with applicable industry standards
Model designs in CAD and generate associated drawings with Geometric Dimensioning and Tolerancing as appropriate for prototyping and production. Build prototypes for evaluation and testing
Conduct Design Reviews and Technical Reviews
Perform relevant design analysis, including analysis of: • Stress • Thermal • Tolerance Stack-up • Failure Modes and Effects • Manufacturability • Reliability • Serviceability
Write test plans and protocols for Verification of Design Requirements
Perform statistical analysis on data
Write reports to summarize results and conclusions
Manage Design Configurations for clear traceability to what was tested
Track and troubleshoot issues that are identified
Continuously improve designs
Continuously improve processes
Contribute and support preparation of 510k submissions
Support Design Transfer
Drive success relentlessly
Work closely with system architects and other design engineers to ensure that the design meets the end users’ needs
Endlessly learn and improve
Other duties as assigned

Qualification

Mechanical EngineeringMedical Device ExperienceCAD ModelingPlastic Injection MoldingDestructive TestingFluid Valve DesignIEC 60601 ComplianceCommunicationProblem SolvingTeam Collaboration

Required

BS in Mechanical Engineering or equivalent experience
10+ years of experience, in some type of medical device company
Excellent communication skills
Experience with plastic injection molding
MUST BE a U.S. Citizen or Green Card holder

Preferred

Experience with destructive testing, such as Highly Accelerated Life Testing
Experience with fluid valve design preferred
Experience in the medical industry or another regulated field
Experience with IEC 60601 preferred

Company

DeBellis Catherine & Morreale - Corporate Staffing

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DCM Staffing is a boutique recruitment firm that focuses on our clients.

Funding

Current Stage
Early Stage

Leadership Team

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Joe Catherine
Partner Recruiter
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Company data provided by crunchbase