Sr. Design Engineer

RXinsider LTD.

Brecksville (OH)

On-site

USD 85,000 - 130,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Benefits offered by this job

On-site gym

Annual employee picnic

Tuition reimbursement

401k match

Paid holidays

Job summary

AMT, near Cleveland, Ohio, seeks a design engineer to lead the development of enteral feeding and surgical devices from concept to finished design. You will manage projects, perform risk analyses, coordinate with cross-functional teams and oversee prototyping, testing, and sourcing.

The role requires 5+ years design experience in medical devices, proficiency with SolidWorks, and familiarity with FDA submissions and injection molding processes.

Qualifications

Requires a minimum of a 4 year bachelor’s degree.
5+ years of relevant design and/or product development experience.
Creative thinker with practical execution.
Excellent communication with medical personnel.
Advanced experience using SolidWorks or similar 3D modeling software.
Medical device development and FDA submission experience is a plus.
Injection molding familiarity is a plus.

Responsibilities

Lead new product design and major improvements for current products.
Oversee overall project management and timeline updates.
Coordinate with engineering and other departments to complete tasks.
Deliver extensive project status presentations.
Conduct risk analyses and define user needs and specifications.
Oversee design validation and clinical evaluation activities.
Prototype and test products; source components and quotes.
Create BOMs and assist manufacturing procedure development.
Transfer design to manufacturing and support ongoing production.

Skills

Creative thinker

Excellent communication

Project management

FDA submissions experience

Injection molding experience

Education

Bachelor’s degree

Tools

SolidWorks

3D Printing

Mold Flow Analysis

FEA

Job description

Description

Since 1985, our core business has been enteral device product development, design, manufacturing, and engineering in a state-of-the-art facility near Cleveland, Ohio. AMT’s steady growth consistently creates job opportunities in Northeast Ohio. We are always searching for new talent and would love for you to join our team! We strive to keep the small company feeling while still reaching users all over the globe.

Position Summary

This person will work on the design and development of new and existing products within the enteral feeding & surgical industries, overseeing projects from concept through finalized design, and coordinating all aspects in between. This will include risk analysis, user need and functional specification determinations, prototyping, material research, component sourcing, BOM creation and manufacturing procedure development. Work is generally independent, but also collaborative in nature with others in the engineering department and sales & marketing.

Duties And Responsibilities

This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties will be required and/or assigned.

New product design & major improvement designs to current products
Overall project management including timeline updates
Coordination within engineering and other departments to complete project tasks
Extensive presentations on project status updates
Risk analysis assessments
User needs and functional specifications determination
Design validation & clinical evaluation oversight
Prototyping & product testing
Vendor correspondence for both obtaining samples and getting quotes
Cost analysis and price breakdown of components and assemblies
BOM creation and manufacturing procedure development
Design transfer to manufacturing & follow-up manufacturing support

Supervisory Responsibilities

None

Requirements

Minimum Qualifications

Minimum of a 4 year bachelor’s degree is required.
5+ years of relevant design and/or product development experience.
Creative thinker, but also practical in getting things accomplished.
Excellent communications skills and ability to meet with medical personnel.
Advanced experience using Solidworks and/or other 3D modeling software.
Medical device development and experience with FDA submissions is a plus.
Injection molding familiarity and/or experience is also a plus.

Language Skills

Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures and/or governmental regulations. Ability to write reports, business correspondence and/or procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, vendors, non-engineers and/or the general public.

Mathematical Skills

Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Essential Job Functions

Mental: Must be able to effectively communicate with others; complete and understand complex analysis of numbers; 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 level and limited exposure to physical risk.

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. Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.

Equipment Used

Solidwork 3D Modeling, 3D Printing, Mold Flow Analysis & FEA.
Injection molding machines to aid in more advanced prototyping.
Tensile Testers, Optical Comparators, Gauges and other QA tools.
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.

Benefits

Insurance: AMT offers major medical, dental, and vision insurance at the first of the month following 30 days of service.
Other Benefits: AMT offers several other voluntary benefits including hospital indemnity, critical illness, term life insurance & long term disability (company paid), among others.
401k: AMT matches 100% of your contribution, up to 3% of your salary.
Paid Time Off (PTO): In addition to nine paid holidays, AMT provides employees with paid time off (determined by length of service), starting on day one

Other Exciting Perks!