Our mid-size cardiovascular client is adding a Principal R&D/Product Development Engineer to the team. The Engineer will lead product development activities from concept to commercialization.

Your role with the company:

• Lead conceptualization, design, and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements
• Acts as leader and/or primary technical contributor for cross-functional development team(s) that manage projects from concept through commercialization.
• Accurately and efficiently translates user and patient needs into verified/validated devices, through creation and refinement of design requirements, design specifications, test methods, and procedures while adhering to design controls best practices.
• Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements.
• Owns verification and validation activities through regulatory clearance and design transfer.
• Manage multiple projects and maintain on schedule while serving as the primary point of contact for management for those projects.
• Drives design reviews and ensures on-time completion of design control deliverables.
• Design, assemble, and evaluate prototype device assemblies to assess the technical feasibility of various solutions.
• May be responsible for direct reports, including reinforcing the open-door policy and ensuring duties, responsibilities, authority, and expectations for direct reports are defined and understood.
• Actively identifies systemic department and organizational improvements as well as product portfolio expansion opportunities; helping to refine our product development strategy and roadmap.
• Interface with physicians and other medical personnel in a professional manner (maintaining confidentiality and intellectual property vigilance.)
• Contribute to design/development of product line extensions and product improvements.
• Author protocols and reports including engineering studies using basic statistical methods.
• Communicate with outside suppliers for component sourcing and refinement.
• Develop and own true clinical expertise around clinical/market focus area including:
  • entirety of disease condition
  • relevant anatomical and systemic knowledge
  • medical management, surgical, and interventional treatment options
  • relevant product & procedural treatment options
  • overall clinical risk vs. benefit assessment

Desired Profile:

• Bachelor’s degree in engineering or related technical field.
• 7 years in product development/R&D at a class 3 medical device company
• Ability to apply analytical skills and technical principles to problem solving and product development.
• Familiarity with statistical techniques
• Demonstrated computer skills preferably Solidworks, spreadsheets, word processing, database, and other applicable software programs.
• Working knowledge of common lab equipment (caliper, micrometer, tensile tester, pressure tester, vision measurement system) and knowledge of lab practices and techniques).