Design Engineer

Our client is seeking a Design Engineer who will develop and support innovative surgical devices, from concept to launch and beyond. The Design Engineer should understand user needs and requirements, balance individual product-level requirements with system-level requirements, resolve complex mechanical design issues, and commit to the highest product quality. Projects will include a mix of new product development, product improvements, and sustaining projects to mitigate challenges related to capacity improvements and the supply chain. Responsibilities include developing, documenting, and validating new product designs, as well as improving existing designs to meet the needs of our customers.

Responsibilities

• Creates design concepts through vendors of rapid prototyping physical models (3D printing, machining, etc.)
• Creates intellectual property by brainstorming novel concepts, writing invention disclosures, and creating rapid prototypes
• 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
• 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 and maintains engineering drawings to company and international drafting standards
• Supports the quality and regulatory processes
• 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
• Works within the non-conformance system to record discrepancies, assists in the review of the non-conformance, and records the results of the Material Review Board (MRB) and associated activities
• Reviews device master records, history records, and other quality-related documents for accuracy and completeness. Assists in performing first article inspections
• Performs testing of medical devices to replicate customer complaints for the evaluation of changes to existing and new product designs
• Designs for manufacturing and automation, sterilization processes, and biocompatibility
• Assesses field reliability data and improves existing product designs as necessary
• Assists in the evaluation of customer complaints on existing product designs
• Participate in the evaluation of non-conforming products to assist in the improvement of existing and new product designs
• Assist in the activities of analyzing repairs for improvement to new and existing devices
• Under limited supervision, contacts customers and sales representatives to resolve technical and quality problems and may provide technical support
• Perform additional activities when needed or as defined by the management

Qualifications

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or Materials Engineering (or related science/engineering area)
• 3-5 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 the use of CAD to create detailed 3D models and engineering drawings. Must be highly capable of using SolidWorks
• Experience creating rapid prototypes and mock-ups, and evaluating designs via testing and rigorous analysis
• A passion for solving tough technical problems - Strong mechanical intuition and persistence to drill down to pinpoint the root cause of problems, solving problems using fundamental principles
• Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements
• Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; SolidWorks strongly preferred
• Hands-on engineering with the ability to work well in a team environment
• Comfortable with all phases of the product development lifecycle, including design, implementation, debugging, verification, qualification, and transfer
• Familiar and Comfortable with concepts of design input, design output, traceability, and risk analysis
• Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis (FEA); familiarity with statistics and design of experiments
• Experience designing plastic components and assemblies
• Excellent interpersonal and communication skills, both written and verbal, and the ability to effectively communicate technical issues
• Familiar with phases of the product development lifecycle, including conceptualization, design, verification, validation, and transfer to manufacturing
• Proficiency in technical writing
• The position may require 10 to 20% of the time to meet with customers.

Location

• Union City, CA

Employee Type

• Direct Placement

Compensation

• $100,000
• Comprehensive benefits package

To move forward, please complete the assessment here.

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp-to-permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at

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