Title:  Staff Engineer, Product Development

Description: 

QUALIFICATIONS

 

 

Required:

  • Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related engineering field from an accredited university
  • A minimum of 8 years of product development experience; OR master’s degree plus 6 years experience

 

Preferred:

  • Advanced Engineering Degree
  • Experience in developing and commercializing regulated medical devices
  • Experience coordinating and driving cross-functional product development teams
  • Experience in root cause investigation and failure analysis
  • Experience in project planning/scheduling and self-regulated time management
  • Experience with plastic injection-molded part design, assembly and fabrication methods, and plastic material properties (resins and silicones)
  • Experience with designing for large scale automation
  • Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)

 

Skills & Competencies:

  • Proficiency in mechanical design fundamentals, solid modeling, tolerance stack analysis, design for manufacturing and assembly, Geometric Dimensioning and Tolerancing (GD&T), and statistical analysis
  • Strong analytical and demonstrated problem-solving skills
  • Excellent verbal communication, technical writing, and presentation skills
  • Demonstrated ability to prioritize tasks and lead a varied workload to meet departmental and company objectives
  • Working knowledge in FDA, CE Regulatory, and/or Design Control processes
  • Demonstrated technical coaching and leadership of peers
  • Strong cross functional internal leadership, communication, influencing and negotiating skills
  • Competent with SolidWorks software
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Outlook)

 

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to operate a computer and other office equipment, such as printer, telephone, etc. 

RESPONSIBILITIES:

  • Lead the design and development of medical device products and components that adhere to company procedures, industry regulations, and customer standards
  • Significantly contribute to the development of new designs and/or processes at all stages, from concept creation to launched product
  • Apply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testing
  • Convert user needs to design inputs and develop statistically sound design verification and validation strategies
  • Develop and review models, drawings, specifications, test protocols, engineering reports, and other associated engineering documentation
  • Promote visibility and transparency of information within product development and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge
  • Provide technical guidance and coaching of other engineers
  • Support project strategies that match Enable product and pharmaceutical partner goals
  • Work with functional managers and project management leaders to contribute to internal project planning and execution to ensure company goals are met
  • Assist to establish and maintain detailed project plans including defining risks through comprehensive mitigation assessment and planning techniques
  • Provide project and technical communication to cross functional teams for devices through clinical development, product registration and commercialization
  • Understand and follow the New Product Development process with a focus on quality
  • Ensure accurate and controlled documents are generated
  • Assist in nonconformance, complaint, and failure investigations
  • Design test fixturing and methods to assess design feasibility and performance limits
  • Identify and communicate product and Product Development related objectives, issues, and risks and facilitate interdepartmental and cross functional discussion on impacts
  • Support strong collaborative relationships with external design and manufacturing partners and service providers


Nearest Major Market: Cincinnati