Senior Design Engineer

CQ Medical Careers•Avondale, PA

About The Position

Responsible for design and technical development in new product development, with a focus on innovative products. The role works with Manufacturing and Project Management to support smooth production startup and provides design or process engineering support for existing products and continuation engineering initiatives. It also provides advanced technical leadership within the engineering group. The Senior Design Engineer designs and develops products primarily outside existing product lines; leads research into new materials, designs, and manufacturing techniques; produces product-development and quality-system documentation; and provides technical input and decision-making on product design. The position works with project engineers to understand and follow schedules, communicates with Manufacturing, Project Management, OEMs, and customers as needed, and develops cost estimates. It also mentors junior designers, engineers, and interns and represents Engineering on technical issues as required.

Requirements

  • Bachelor's degree in engineering from a four-year college or university, or an equivalent combination of education and experience.
  • At least eight years of related experience and/or training.
  • Experience following ISO 9001 processes.
  • Knowledge of intellectual property and patent concepts, with the ability to communicate those concepts to engineering staff.
  • Skills in design, documentation, materials management, design for manufacturing, process management, design software management, troubleshooting, and problem solving.
  • Interpersonal, organizational, and time-management skills.
  • Experience with Microsoft Excel, Microsoft Word, and Microsoft Project.
  • Ability to perform the essential duties satisfactorily, with reasonable accommodations available for individuals with disabilities.

Nice To Haves

  • Experience with ISO 13485, ISO 14971, FDA, and MHLW requirements.
  • Related product and equipment knowledge.
  • Experience with manufacturing processes such as injection molding, machining, and assembly.

Responsibilities

  • Design and develop products primarily outside existing product lines, with a focus on new and innovative products.
  • Lead research and investigation into new materials, product designs, and manufacturing techniques.
  • Generate product-development, quality-system, and project documentation as needed, including DHF documents, work orders, and charters.
  • Provide technical input and make advanced technical decisions related to product design.
  • Use CAD systems, advanced analysis tools, and manufacturing processes with expert-level knowledge.
  • Work with project engineers to develop and understand project schedules and work within them.
  • Communicate regularly with Manufacturing and Project Management throughout projects.
  • Communicate with OEMs and customers on technical matters as needed.
  • Develop cost estimates for projects and products.
  • Follow engineering and company processes, including applicable quality processes.
  • Attend relevant training, keep current with technology developments, participate in clinical evaluations, and pursue further training and education.
  • Mentor junior Mechanical Designers and entry-level Engineers on CAD systems and provide technical guidance to junior engineers and interns.
  • Advise staff on CAD-related problems and capabilities and provide technical leadership within Engineering.
  • Represent Engineering in capacities such as CO and MRB on technical issues as required.
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