System Design Engineer

The System Design Engineer will serve as the systems and mechanical lead for developing complex, electro-mechanical products for the consumer health and medical device markets. This individual is responsible for all aspects of product life cycle management in the area of product development, from inception through engineering design and manufacture and works in concert with Simbex Project Owners and Project Engineers to deliver novel product solutions within constraints of budget, schedule, and established quality processes and methodologies.

RESPONSIBILITIES:

• Develop conceptual and detailed designs by analyzing product requirements and performance requirements
• Create system and mechanical design architecture plans through use of block diagrams, sketches, development timeline outlines with key technical milestones
• Collaborate with senior system design engineers and project engineers to give technical guidance for project level decisions as well as estimating development and manufacturing times and costs for input to project plans
• In collaboration with senior systems engineers, foresee and present high risk development items from product requirements and appropriately de risk items early in development through use of breadboards, proof of concept units, and bench prototypes
• Use 3d modeling, simulation and other engineering tools to create mechanical design packages according to requirements
• Perform diverse and complex design, fabrication, modification, and evaluation of mechanical or electromechanical components, subsystems, and systems by applying engineering principles and developing new or unique analysis tools as required
• Provide technical information affecting long range product engineering planning by researching manufacturing or processing techniques, materials, properties, and process advantages and limitations
• Advise project teams and customers and implement most efficient method of component manufacturing depending on project goals
• Responsible for the creation of component and subsystem design verification plans and test methods, and test results, as well as performing testing
• Investigates pertinent design factors such as human factors and ergonomics, ease of manufacture, availability of materials and equipment, interchangeability, strength-weight efficiency, contractual requirements, cost efficiency, and implements recommendations
• Reviews drawings and layouts to ensure clarity, completeness, functionality, and conformity to standards, procedures, and specifications.
• Engage and manage outside vendors for prototyping, gathering manufacturability feedback and cost and lead-time estimates
• Ensures internal project documents are complete, current, and stored according to Simbex’s Quality Management System
• Concisely and accurately communicates development progress and results to internal and external customers (both written and verbal)

REQUIRED QUALIFICATIONS

• Bachelors degree (BS) in mechanical, electro-mechanical, or a related technical discipline with 4 years of medical device and/or combination product development experience
• Demonstrable experience in solving a wide range of difficult problems in imaginative and practical ways, and evaluation of alternative solutions that require coordination across multiple teams
• Demonstrated experience bringing an electromechanical product or assembly through its entire lifecycle from initial concept to finished good manufacturing
• Ability to work with vague project and product requirements from various sources and distill into implementable feature
• Strong ability to develop high quality, easy to understand, specifications, analyses, and related design documentation
• Familiarity with design for electromechanical regulatory standards such as UL, CE
• Experience with effectively creating risk analysis docs such as FMEAs and hazard analyses.
• Solidworks CAD proficiency with experience in advanced part modeling and surfacing techniques
• Strong experience with design for prototype, low, med, and high volume manufacturing across various processes including injection mold, urethane casting, metal casting, sheet metal, etc.
• Ability to create high quality system and mechanical specifications and drawings including use of GD&T, appropriate tolerances per manufacturing capability, applicable notes, detailed system level BOMs
• Experience with materials selection, basic pneumatics, fluids, and thermal analysis
• High level of clear and concise communication to effectively present complex topics to external customers, project management and other engineers
• Strong organizational skills and attention to detail
• A commitment to our core values of innovation, passion, agility, openness, integrity and social responsibility

PREFERRED QUALIFICATIONS

• Experience with electromechanical medical device design and documentation
• Familiarity with design for IEC 60601
• Ideation, industrial design, concept development and sketching experience
• Understanding of systems engineering practices such as requirements management, risk analyses, design trade-off and cost-benefit analysis

Salary : $110,000 - $130,000