Dev Sr Engineer I presso Highridge Medical

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.

We are seeking a Senior Development Engineer I responsible for the design and development of spinal implants and instruments.  The role supports both new product development and sustaining engineering. This individual will lead small-scope projects and serve as a core team member on larger efforts. The engineer is expected to interact directly with surgeons and cross-functional stakeholders such as Marketing, Regulatory, Quality, Testing, and Sales. In the role they should also demonstrate initiative in managing project execution. Occasional travel and mentoring of junior engineers may be required.

Principal Duties and Responsibilities:

• Contributes to the design and development of new products and improvements to existing products from conception to launch following Design Control procedures. 
• Contributes to and leads the creation of project plans and manages critical project timelines.   
• Develops innovative solutions in a team environment to address clinical problems and translates ideas into concepts, functional prototypes and ultimately a commercialized product.  
• Collects surgeon feedback and defines user needs, specifications, and performance criteria. 
• Generates CAD models and engineering drawings primarily within Solidworks.
• Authors and maintains design control documentation within a DHF.
• Supports test strategy development and contributes to test protocol/report creation.
• Defines and executes verification and validation activities with support from testing and quality teams.
• Designs components for manufacturability, inspectability, and cost-effectiveness.
• Ability to manage multiple smaller projects at one time throughout all states of the development process. 
• Participates in root cause investigations and corrective actions.
• Contributes to generation of comprehensive protocols and reports for ASTM testing or evaluation of products.
• Contributes to invention disclosures and IP generation. 

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• Full working knowledge of and moderate level of experience with new product development, including familiarity with design control processes.
• Demonstrated ability to methodically investigate technical issues, identify appropriate solutions, and apply current technologies to resolve problems
• Ability to develop and maintain project schedule and track cross-functional team progress to meet deadlines 
• Ability to identify customer complaints, process engineering change requests, address nonconforming product, and provide sound technical recommendations
• Professional, concise, tactful, and sensitive in communications with internal teams and external stakeholders, including surgeons and suppliers
• Accomplishes objectives when communicating with internal personnel, and external customers and vendors. 
• Effective written and verbal communication skills, including the ability to create and deliver technical presentations
• Working knowledge of drafting standards and geometric dimensioning and tolerancing (GD&T)Working knowledge of drafting standards and geometric dimensioning and tolerancing 
• Familiarity with and ability to support Quality Assurance and Regulatory requirements applicable to the medical device industry
• Ability to manage and set priorities on multiple projects at one time 
• Proficient in CAD design and engineering drawings, preferably using SolidWorks
• Proficient with Microsoft Office Suite and MS Project

Education/Experience Requirements 

• Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering. 
• 3-5 years of experience in the Medical device industry, particularly in Orthopaedic devices

Travel Requirements

• Up to 10%