Product Development Engineer 13412

Job Description

Product Development Engineer

Primary Responsibilities

• Research, develop, and design spinal implants & instruments following FDA and ISO requirements. New Product Development as well as maintenance of existing legacy systems.
• Support identification and timely execution of product development process and project deliverables, including concept design, testing, design finalization, verification/validation activities, transfer, and launch support.
• Execute development activities of complex line extensions and special instrument modifications in an abbreviated schedule with the assistance of Senior Engineering Staff.
• Create designs using CAD (SolidWorks) for subtractive and additive manufacturing methods. Generate 3D part files, 3D assembly files, & 2D technical drawings.
• Write protocols, execute, analyze test data, and generate reports to verify or validate that designs meet functional and performance specifications, including interactions with outside testing facilities.
• Generates and manages the Change Order process for initial release & revision of device-related changes, including potential impacts on current design inputs, risk, and relevant controlled documents in the system Design History File.
• Competent interface with ALL customers (Surgeons, Distributors, FDA, Manufacturers, Consultants, Etc.) to discuss design inputs, functional instruction, and current challenges for new product development and legacy systems. Collaborate with senior engineering and cross-functional departments to identify and ensure project team and senior management are a
• Aware of upcoming milestones and risks/issues.
• Utilize in-house rapid prototyping and interface with suppliers to provide support during the manufacturing process.
• Review and approve product Inspection Standards, overlays, and gauges in collaboration with the Quality department.
• Comfortably provide technical assistance to other areas of the organization including, but not limited to, Sales, Marketing, Quality, Regulatory, Purchasing, Sales Support and Executive Management.
• Conduct static and fatigue stress analysis on developed designs using FEA, including interpretation of results.
• Collaborate & offer background, knowledge, & expertise with other Group staff.
• Follow organizational & group guidelines, procedures, and protocols.
• Assist senior engineering staff and patent counsel in preparing invention records and assisting in the patent submission process.
  
  

Qualifications

• Proficiency with CAD software required (SolidWorks preferred).
• Working knowledge & experience with product development cycle and phased/gate approach of small projects.
• Familiarity with general manufacturing processes and common materials used to produce medical implants and instruments. Familiarity with Additive Manufacturing preferred.
• Experience with GD&T, stack-up analysis, and mechanical testing preferred.
• Exposure and familiarity with relevant ASTM, ISO, and FDA standards, regulations, and guidelines.
• Comfortable with the autonomy of responsibility in addition to a team environment.
• Be adept and flexible in managing multiple tasks at once while keeping to the set schedule of each task.
• Capable of presenting and sharing information with management, surgeons, and/or field personnel when requested (PowerPoint skills preferred).
• Ability to read, write, and interpret technical documents such as engineering drawings, regulations, company policies, and procedures.
• Competent in basic science and engineering principles, including physics, algebra, and statistics, with the ability to understand and solve technical problems, collect and analyze data, draw valid conclusions, and communicate findings.
• Familiarity with Project Management planning preferred (MS Project, Smartsheet, etc.)
• Experience in identifying and investigating issues, proposals of appropriate solutions, and implementation aid to resolve the problem.
  
  

EDUCATION And EXPERIENCE

• BS in Mechanical Engineering or Biomedical Engineering or equivalent
• 3-6 years of experience preferred.
• Product development experience preferred.
• Spinal or Orthopedic Implant design experience preferred.
  
  

Summary

Under routine guidance, primarily responsible for designing and developing new spinal products/product families and/or enhancing existing products. Involved in creating designs, modeling, and drafting, utilizing a 3D CAD system. Other responsibilities include assisting in the development process with Marketing, Purchasing, Manufacturing, Quality, and Regulatory to help complete delegated tasks from project conceptualization through full market launch.

TriMech Services is an engineering resource provider specializing in the placement of qualified technical candidates for both temporary and direct hire opportunities. TriMech Services offers a unique approach to matching the specialized skill sets of our candidates to our clients engineering specific requirements.

Company Description

TriMech Services specializes in the placement of qualified technical candidates for both temporary and direct hire opportunities. TriMech Services offers a unique approach to matching the specialized skill sets of our candidates specific industries.

TriMech Services specializes in the placement of qualified technical candidates for both temporary and direct hire opportunities. TriMech Services offers a unique approach to matching the specialized skill sets of our candidates specific industries.