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Title:  Staff Engineer, Product Development

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

LOCATION: Cincinnati, OH

 

PURPOSE OF POSITION:  The Staff Engineer, Product Development performs product design and development activities for both new and sustaining projects. This individual will work cross functionally to assure specifications are met with technically strong, high quality, cost effective designs following a defined development process.

 

QUALIFICATIONS

 

 

 

Required:

 

  • Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related 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 with cross-functional product development teams
  • FEA/CFD modeling experience
  • Experience with plastic injection-molded part design
  • Experience with designing for large scale automation

 

Skills & Competencies:

 

  • Proficiency in mechanical design fundamentals, solid modeling, tolerance stack analysis, design for manufacturing, Geometric Dimensioning and Tolerancing (GD&T), and statistical analysis
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
  • 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 team and departmental objectives
  • Possesses working knowledge in FDA, CE Regulatory, and New Product Design processes
  • Demonstrates technical coaching and leadership of peers
  • Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)
  • Strong internal leadership, influencing and negotiating skills
  • Competent with SolidWorks software
  • Demonstrated ability to provide cross-functional communication

 

RESPONSIBILITIES:

 

  • Lead the design and development of medical device products and components that adhere to company procedures, industry regulations and customer standards
  • Apply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testing
  • Convert user needs to input, develop statistically sound design verification and validation strategies, and conduct risk management activities
  • Develop product specifications, drawings, test protocols and reports
  • Generates design history files following FDA and international standards
  • Work with functional managers and partners to ensure project goals are met
  • Contributes to internal project planning and execution to meet schedule and budget requirements
  • Provide project and technical communication to cross functional teams for devices through clinical development, product registration and commercialization
  • Significant contributions to the development of new designs and/or processes at all stages, from concept creation to launched product
  • Produces design models, drawing details, assembly drawings, and associated engineering documentation with 3-D parametric modeling software, MS Word, MS Excel and MS Power Point
  • Assist to establish and maintain detailed project plans, define risks and recommend contingency plans as required.
  • Ensure accurate and controlled documents are generated
  • Assist in deviation, complaint and failure investigations
  • Support operational planning activities ensuring alignment to program strategy
  • Promote visibility and transparency of information within product development and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge
  • Assist with identifying and communicating product and Product Development related objectives, issues, risks, and where applicable, facilitate cross-PD discussion on impact
  • Support project strategies that match Enable product and pharma partner goals
  • Understand and follow the New Product Development process with a focus on quality
  • Assist with identifying project risks through comprehensive mitigation assessment and planning techniques and work with partners to develop project plans and project risk analyses for all assigned projects.
  • Provide technical guidance and coaching of other engineers
  • Assists in project planning and assures alignment with leadership objectives and priorities
  • Supports strong collaborative relationships with external design/development, manufacturing partners and service providers

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.