Senior R&D Engineer at our lab in Toledo, Ohio

The Sr. R&D Engineer will work as part of a cross-functional team to design and develop implants and instrumentation for new platform technologies, as well as develop improvements and modifications to current products.

In this role, the successful candidate will interact with marketing, quality, manufacturing, regulatory affairs, and sales consultants to define product requirements and develop design concepts. This may involve collaborating with treating physicians to understand clinical needs, define design parameters, develop design concepts, and evaluate prototypes via benchtop and cadaver testing evaluation, thus ensuring the product meets customer needs.

Heavy emphasis will be on mechanical design work, including generating product models, concept layouts, and engineering prints using CAD software. The candidate will also: develop mechanical test protocols according to industry standards and coordinate the activities required to fabricate test parts and complete mechanical testing; apply principles of design for manufacturability to ensure  the product design can be mass-produced on a cost-effective basis; and ensure compliance with FDA Design Control regulations and support regulatory filings.

Responsibilities

• Responsible for all phases of product development, including defining customer requirements, designing concepts, manufacturing transfer and product launch.
• Conduct performance testing for product characterization and design verification and validation.
• Coordinate with vendors, managers, and other units (as needed) to ensure specific cost, time and/or regulatory standards are met.
• Generate new intellectual property via invention disclosures and patent filings; provide technical review of competitive patents.
• Complete engineering drawings and engineering change orders.
• Prepare technical documentation.
• Apply good engineering practices and principles.

Qualifications

• Bachelor's degree in Mechanical or Biomedical  Engineering.
• Minimum of 4 years of product design/development experience (or 2+ years with a Master's degree); experience in the medical device or other regulated industry preferred.
• Experience in mechanical design principles, material selection, verification and validation of design concepts, and understanding  design failure modes.
• Knowledge of CAD software, i.e., ProEngineer, SolidWorks, etc.
• Proficiency utilizing Microsoft Office.
• Must have the ability to effectively communicate concepts, ideas and knowledge.
• Must be able to work effectively as a team member.