Responsible for providing support of research, engineering, and product development activities for development of a novel osseointegration surface morphology, Auxano. Activities are performed on projects with some guidance and direction.
These activities are performed on single projects of limited scope or in support of larger scale projects. The scope of work typically encompasses moderate technical difficulty. This position is expected to execute project and design tasks with minimal technical supervision and some overall management.
Essential Job Functions:
- Uses an organized approach to identify key constraints when designing and problem solving, considers an appropriate range of options and chooses an optimal solution.
- Generates unique, creative concepts that are innovative and technically sound solutions to challenging design problems.
- Participates in technical discussion on the merits of designs as they relate to the application of the pillar surface to orthopedic (hard tissue) and other tendon/ligament applications.
- Participates in design meetings with researcher, surgeons and AMT personnel
- Completes assigned tasks at an aggressive pace.
- Provides support in creating appropriate test plans. Executes test plans with moderate guidance.
- Assists in writing technically sound test protocols and reports documenting the testing performed.
- Supports product launches through OR observation, surgeon & sales representative training, and design updates based on initial surgeon feedback.
- Writes defendable rationale for design changes to existing products (both Class I and Class II).
- Prepares clear, technically correct design documents based on AMT SOPs and documentation conventions.
- Provides support in the preparation of 510(k) submissions, along with risk analysis, with excellent attention to details
- Reviews information for patent applications. Works with Legal staff to ensure accurate, thorough, and complete patent applications to cover innovative design output.
- Presents a professional image to researcher, surgeons, and other customers.
- Interacts with customers and surgeons at trade shows in support of sales and marketing.
- Requires up to 10% travel depending on current project status and needs, new product launch support, and on-going field needs.
- Puts in time that is required to fulfill duties (job scope frequently requires significantly more than 40 hrs/week, including some weekends).
- Tracks project expenses as well as cost analysis.
- Vendor sourcing.
- Bone reaction and manufacturing procedures.
- Coordinate cross-functional project tasks within various departments (e.g. Design, QA/Regulatory, Sales/Marketing and Manufacturing Engineering) and outside resources to meet timelines.
- Hold periodic project review meetings to update team with status and/or make management aware of delays in project.
- Adhere to AMT Phase Gate process, pushing project through necessary approvals.
- Other duties that may be required and/or assigned.
Required Experience: *
- Able to apply basic time management skills to assigned tasks and use of applicable resources.
- Supports design and development efforts from conception through prototyping and production with a moderate amount of management interaction and guidance
- Learns about and demonstrates understanding of bony anatomy and biomechanics, as applicable to assigned projects. Learns about and demonstrates understanding of soft tissue repair concepts and techniques.
- Has a basic understanding of manufacturing processes and how they affect design decisions.
- Learns about and demonstrates understanding of surgical techniques and terminology relating to assigned project area.
- Familiar with or learns about mainstream competitive products and procedures relating to assigned projects.
- Has a basic understanding of design analysis. Uses appropriate tools (stress analysis, FEA, etc.) to verify the integrity of designs.
- Proficient in Solidworks including 3D modeling and 2D drawings.
- Working knowledge of GD&T. Able to apply basic GD&T principles to engineering prints.
- Is a self-starter. Capable of working with little to no supervision.
- Able to operate testing equipment relevant to product development.
- 3- 5 years of product development experience with focus on medical devices, preferably in orthopedics.
- Bachelor of Science degree in mechanical or biomedical engineering.
- Advanced technical degree preferred.
- Medical / Orthopedic experience preferred.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Essential Job Functions:
Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.
Mental: Must be able to effectively communicate with others; read, analyze and interpret written materials; meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems.
Physical: Must be able to hear and verbally communicate for hours at a time, use computer equipment, electrical, and general hand tools. Moderate noise levels and limited exposure to physical risk are expected. Without assistance, must be able to lift to 50 lbs on occasion, sit, bend, squat, twist, stand, climb, and walk for hours at a time. Must have good eye-hand coordination and ability to handle repetitive tasks.
Knowledge, Skills, and Abilities Required: Knowledge of modern business communication, office procedures and methods. Skill to use a personal computer and various software packages such as Microsoft Office Suite. Proficient in Excel a plus. Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.
- Telephones, computer, other office equipment as needed.
- Ability to operate electrical hand tools and general hand tools.
- Any basic machining capabilities is also a plus.
Certificates, Licenses, Registrations:
Maintains a valid Driver’s License.
Special / Additional Requirements: * Persons in this position may be required to pass a drug, alcohol, and/or criminal background check.*
AMT is an Equal Opportunity / Affirmative Action Employer
From: Applied Medical Technology, Inc.
Job Type: Full-time