Title:  Senior Engineer, Product Development

Description: 

QUALIFICATIONS

 

 

Required:

  • Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university.
  • A minimum of 6 years of product development experience; OR a master’s degree plus 4 years’ experience.

Preferred:

  • Experience in developing and commercializing regulated medical devices.
  • Experience with plastic injection-molded part design.
  • Proficiency in SolidWorks.
  • Experience with designing for large scale automation.
  • Experience with Schedule development.

 

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 creative problem-solving skills.
  • Excellent verbal communication and technical writing skills.
  • Demonstrates technical coaching and leadership of peers.
  • Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.
  • Demonstrated ability to execute long-term product development deliverables.

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time.
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
  • Ability to move about inside the office to access file cabinets, office machinery, etc.
  • Wear clean room gowns, hair nets, gloves, safety glasses, and shoe covers for extended periods of time.
  • Ability to operate lab instrumentation and equipment.

 

RESPONSIBILITIES:

  • Lead the development of new designs and/or processes at all stages, from concept creation to launched product.
  • Understand and follow the New Product Design process with a focus on quality.
  • Apply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testing.
  • Develop product specifications, drawings, test protocols and reports.
  • Convert user needs to input, develop verification and validation strategies, and conduct risk management activities.
  • Develop verification and validation strategies and conduct risk management activities.
  • Generate design history files following FDA and international standards.
  • Identify product risks and mitigate through design and process improvements.
  • Provide technical guidance and coaching of other engineers.
  • Provide project and technical communication to cross functional teams for devices through clinical development, product registration and commercialization.
  • Contribute to the creation of design control elements to comply with medical device regulations.
  • Contribute to internal project planning and execution to meet schedule and budget requirements.
  • Work with functional managers and partners to ensure project goals are met.
  • Support manufacturing process development.
  • Ensuring accurate and controlled documents are generated.
  • Contribute to a dynamic start-up environment.
  • Produces design models, drawing details, assembly drawings, and associated engineering documentation with 3-D parametric modeling software.
  • Directly communicate with partners translating their needs to product design.    


Nearest Major Market: Cincinnati