New Product Development Engineer

Brief Description

We will be looking at both entry-level and experienced candidates for this position.

The NPD Product Development Engineer is responsible for developing, designing, testing, and inspecting new products while adhering to all regulatory and company requirements as applicable.

Essential Functions

• Responsible for technical inputs and regulatory inputs from statutory standard requirements (especially regarding safety).
• Review and gather data from the following sources for design input:
• Customer input, including complaints and customer feedback.
• CAPA data.
• Non-conforming product data.
• Data on competing products.
• Industry trends.
• Follow AMHI stage/gate design process and perform tasks as required in the Design Control Software.
• Monitor design projects to ensure design deliverables are being completed as required.
• Working knowledge of mechanical and visual design elements including strengths of materials, life cycle or durability calculations, visual design elements, aesthetics, ergonomics, etc.
• Create conceptual designs as assigned and/or assist as needed.
• Create prints to specification and maintain prints for clarity, completeness, conformance to standards and procedures, specs, and dimensions.
• ECO’s (Engineering DCR’s) – initiate, monitor, and complete tasks necessary to close.
• Design criteria for internal product testing regarding safe and effective use of the medical device, which includes writing test protocols and reports, testing and validation of designs.
• Perform risk evaluation/update Risk Management files as required.
• Collaborate with vendors to set & obtain specifications and on any quality/design issues.
• Check completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and dimensions.
• Work with Beta to Launch team to bring protypes to market.
• Responsible for maintaining the Item Master.
• Support Marketing as needed with visual aid from CAD systems.
• Observe Safety Program
• Maintain a clean and safe work area.
• Report potentially unsafe conditions.
• Use equipment and materials properly.
• Utilizes appropriate personal protective equipment where/when necessary.
• Contributes to a respectful, non-hostile, non-violent work environment.
• Understands the purpose, value, and impact work has on product customers and users.
• Other duties as assigned.
  
  

New Product Development Specific Duties

• Ability to perform process and equipment validations and complete the appropriate validation reports.
• Investigate design factors such as ease of manufacture, availability of materials and equipment, interchangeability, cost, etc.
• Create Production Work Instruction books /Assembly Drawings.
• Create BOMs, routings, and pricing in company software systems (NetSuite).
• Coordinating with vendors to source /quoting for new components.
  
  

Requirements

EDUCATION AND/OR EXPERIENCE

• Bachelor Degree in Mechanical Engineering, Biomedical Engineering, or related field required.
• Working knowledge of experimental design.
• Skills to use personal computer and various software packages (Excel, Word, Grand Ave, SolidWorks, 3D & FEA software, email, etc.).
• Project management, leadership, communication/presentation, teamwork, result driven, problem solving, and analytical thinking skills.
• Excellent oral and written communication skills.
• Self-starter, motivated, possess a creative and analytical thought process, growth minded; skills to organize/plan/prioritize work; ability to perform administrative activities; ability to contribute to building a positive team spirit.
• Exceptional technical and problem-solving skills and reasoning ability.
• Ability to read, understand, and follow written and verbal instructions.
• Ability to read and interpret prints.
• Ability to monitor own work to ensure quality.
• Demonstrate accuracy and thoroughness.
• Ability to complete checklists, documents, and reports.
• Strong attention to detail and organization.
• Good manual dexterity.
• Ability to work independently with limited supervision.
• Apply feedback to improve performance.
• Supports organizations goals and values.
• Completes work in a timely manner and is consistently at work on time.
• Strives to increase productivity.
• Generate suggestions for improving work.
• Decision making skills.
• Ability to adapt to a changing work environment.
  
  

Physical Requirements & Work Environment

• Lift up to 25 pounds.
• Ability to sit and use computer most of the workday.
  
  

Summary

Beyond pay, our market-leading benefits are designed to support your wellbeing. These include medical, dental, vision, and life insurance, as well as short- and long-term disability coverage. We also provide a health savings account with company match, a retirement plan with employer contributions through Vanguard, and access to the Granite Assistance Fund for support when it’s needed most. We value time for rest and personal growth, offering generous paid time off, including volunteer time off and paid holidays.