Design Engineer

Overview

Design engineer developing surgical devices from concept through launch using SolidWorks.

Key Responsibilities

• rapid prototyping
• engineering analysis
• device testing
• cad drafting
• technical support
• quality review

Tasks

-Creates intellectual property by brainstorming novel concepts, writing invention disclosures, and creating rapid prototypes -Under limited supervision, contacts customers and sales representatives to resolve technical and quality problems and may provide technical support -Performs testing of medical devices to replicate customer complaints for the evaluation of changes to existing and new product designs -Works within the non-conformance system to record discrepancies assists in the review of the non-conformance and to record the results of the Material Review Board (MRB) and associated activities -Performs engineering analyses of parts and assemblies (FEA, fatigue, manufacturability, FMEA, root cause analysis, DOE creation). Establishes and maintains systems for continuous improvement by capturing user feedback and other data to improve existing and new designs -Creates design concepts through vendors of rapid prototyping physical models (3D printing, machining, etc.) -Reviews device master records, history records and other quality-related documents for accuracy and completeness. Assists to perform first article inspections -Assesses field reliability data and improves existing product designs as necessary -Assists in the activities of analyzing repairs for improvement to new and existing devices -Designs for manufacturing and automation, sterilization processes and biocompatibility -Participates in the evaluation of non-conforming product to assist in the improvement of existing and new product designs -Assists in the evaluation of customer complaints on existing product designs -Supports the quality and regulatory processes -Creates and maintains engineering drawings to company and international drafting standards -Abides by the documentation for product development that aligns with the company's Quality System and meets or exceeds requirements of the FDA's 21 CFR Part 820 regulations and ISO 13485 standards -Serves as lead technical designer, providing technical advice and mentoring the junior design engineers, working on cross-functional project teams to develop new, world-class surgical devices

Requirements

• solidworks
• bs mechanical
• 5+ years
• technical writing
• mechanical design
• fea

What You Bring

-Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer -BS Mechanical Engineering, Biomedical Engineering, or Materials Engineering (or related science/engineering area) -Familiar and Comfortable with concepts of design input, design output, traceability, and risk analysis -5+ years of experience developing medical products. Experience with metals or reusable surgical instruments is a plus -Must be highly capable using Solidworks. Skilled in mechanical design and use of CAD to create detailed 3D models and engineering drawings. Must be highly capable of using SolidWorks -Proficiency in technical writing -Experience designing plastic components and assemblies -Experience creating rapid prototypes and mock-ups and evaluating designs via testing and rigorous analysis -Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; Solid works strongly preferred -Familiar with phases of the product development lifecycle, including conceptualization, design, verification, validation, and transfer to manufacturing -Hands-on engineering with the ability to work well in a team environment -Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials and stress analysis (FEA); familiarity with statistics and design of experiments -Excellent interpersonal and communication skills, both written and verbal, and ability to effectively communicate technical issues -Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements -A passion for solving tough technical problems - Strong mechanical intuition and persistence to drill down to pinpoint root cause of problems, solving problems using fundamental principles

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Benefits

-Pay Rate: $80K - $93K Base USD Yearly

About Raise

-Born from the 65-year legacy of Ian Martin Group, this company rethinks staffing with tech-first, self-managed operations. -Operates globally with offices in the US, Canada, Ghana, India, and the Philippines, offering permanent placement, contract recruitment, payroll/EOR, RPO, and total talent management. -Skilled trades, technical, and industry-specific teams support clients across IT, energy, manufacturing, healthcare, transportation, and more. -Tech platform uses AI-driven insights and real-time scheduling to enhance hiring speed and candidate experience. -Employs a Teal-operating, self-managed model, empowering employees to drive agility and innovation.

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