- Leads the design and development of new products as part of a project team. Identifies all tasks required to complete project assignments according to Design Control procedures. Creates project plans and manages critical project timelines.
- Generates creative solutions to address clinical problems. Must work well in a team environment to brainstorm ideas. Ability to translate ideas into working concepts.
- Manages multiple projects at one time throughout all states of the development process.
- Collects surgeon input (voice of customer) and develops definitive new product specifications or modifies existing specifications to satisfy unique needs.
- Generates CAD models and engineering drawings.
- Generates or updates design control documentation for the product, including design history files.
- Completes design verification and validation activities on new or existing designs.
- Generates and/or manages the creation of prototypes to evaluate new design concepts.
- Designs for manufacturability, inspectability and optimum cost/efficiency. Prepares quotes outlining estimated manufacturing costs.
- Participates in root cause analysis for problem solving.
- Contributes to generation of a comprehensive protocol for testing/analyzing the product.
- Full working knowledge of and moderate level of experience with new product development.
- Demonstrated ability to methodically investigate, determine appropriate solutions, and resolve problems using current technology.
- Ability to develop project schedule and assess cross functional teams' progress on assignments relative to project schedule
- Ability to identify customer complaints, process engineering changes and handle nonconforming product, and make recommendations based upon business principles
- Professional concise, tactful, and sensitive in communications.Accomplishes objectives when communicating with internal personnel, and external customers and vendors.
- Demonstrates good written and verbal communication skills including presentation skills
- Working knowledge of drafting standards and geometric dimensioning and tolerancing
- Familiarity with and ability to assure Quality Assurance requirements of 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
- Office Suite and Project
- 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 Orthopedic
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Sr. Development Engineer I - Westminster, United States - Highridge Medical
Description
*********No Third-Party Recruiters*********
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.
Job Summary:
Responsible for the design, development, and processing of spinal implants and instruments. Work is expected to encompass both the development of new products and maintenance of existing products. Position will lead small scope projects as a project leader and as a core team member. Engineers are expected to communicate with surgeons, healthcare professionals, and cross functional teams (Marketing, Regulatory, Quality, Testing, Sales). Position may be required to travel. Position may be required to provide on-the-job training to new engineers.
Principal Duties and Responsibilities:
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)
Education/Experience Requirements
Travel Requirements
Up to 10%
Salary: $73,040 - $95,866
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