Custom Search - Logo

Sr./Principal Product Development Engineer

Twitter Facebook
Job Type
Direct Hire
Nov 15, 2018
Job ID
Our 12 person small R&D facility is adding a Sr/Principal Product Development Engineer to the team.  The medical device company develops and manufactures minimally invasive, single-use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products they develop and manufacture are typically market disruptive and displace higher cost procedures.

Your role with the company:
  • Work collaboratively with other engineers and personnel from client companies assigned to a development project
  • Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions
  • Translate user needs and other customer input into clear, concise design requirements and design concepts.
  • Create and document design concepts through the use of 3D CAD software and rapid prototyping methodologies
  • Create concept models and prototypes utilizing small tools and equipment.
  • Create specifications for device components, assemblies, packaging, and labeling
  • Work with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing.
  • Assist in the identification and selection of outside suppliers and consultants as required.
  • Prepare for and conduct various design reviews in accordance with regulatory requirements
  • Verify that designs meet functional requirements through the performance of engineering analyses and testing.
  • Assist in the development of test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
  • Prepare for and facilitate risk assessments throughout the product development lifecycle.
  • Utilize common laboratory test equipment to perform hands-on mechanical and electrical testing.
  • Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
  • Specify fixtures, gauges, and equipment needed for the verification and manufacture of small quantities of prototype devices
  • Work with clients and client patent counsel to prepare invention records and assist in the patent submission process.
  • Provide technical support to manufacturing engineering for design and process improvements made post transfer to sustaining manufacturing.
  • Participates as a member of a Product Development project team.  The role of the PDE is to contribute to the technical aspects of project including product design, verification, and validation.
  • Be responsible for meeting overall project deliverables and objectives.
  • In a non-supervisory capacity, provide coaching, and guidance regarding project tasks to other engineers, designers, technicians, and associates.
  • Promote employee development and foster growth of employees through effective mentoring
Desired Profile:
  • Bachelor of Science engineering degree, BSME or BSBME (or related discipline) 
  • 5 - 10 years’ experience in product development for a manufacturing company in the medical device industry: catheters, extrusion, and electrophysiology (EP) systems
  • Extensive experience with Solidworks is required
  • Technical product development experience, e.g. design, process, or quality engineering
  • Working knowledge of both FDA and CE design controls
  • Strong technical writing ability.
  • Leadership ability and organizational skills.
  • Strong team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.