New Product Development Engineer

Orchid Orthopedic Solutions LLC; Woburn (MA); Remote; USD 70,000 - 110,000; Full time

Job summary

Orchid Orthopedic Solutions LLC is seeking a New Product Development Engineer for a remote role with preference for candidates near our plants in Warsaw, IN, Claypool, IN or Kenosha, WI. The position involves designing, prototyping, and evaluating medical device components within a structured development process.

Responsibilities include working on cross-functional teams, performing tolerance analyses, DOEs, and supporting validation testing and manufacturability improvements.

Qualifications

• BA/BS in Engineering is required.
• Knowledge of tolerancing, GD&T, and moldability.
• Experience with CAD in medical device product development.

Responsibilities

• Participate in cross-functional teams through all product development phases.
• Define user needs, create design concepts and prototypes, perform tolerance analysis and FEA.
• Assist in process validation plans and testing.
• Support manufacturability improvements with designers and suppliers.

Skills

CAD

GD&T

FEM/FEA

Mold design

Project management

3D CAD

DOE

QA/regulatory knowledge

Medical device industry

Communication

Education

BA/BS in Engineering

Tools

SolidWorks

AutoCAD

Job description

New Product Development Engineer

This is a REMOTE role but ideal candidate should be close to a plant (Warsaw, IN., Claypool, IN., or Kenosha, WI.)

Position Summary

The New Product Development Engineer performs assignments that require the application of standard engineering techniques and processes. The assignments will have clear and specified objectives and require the investigation of a limited number of variables. A moderate exercise of judgment is required on details of work and in making selections and adaptation of engineering alternatives. The Engineer I will receive general direction on new aspects of assignments. The work performed will involve conventional types of plans, investigations, structures, or equipment with relatively few complex features for which there are precedents.

Principle Responsibilities

• Participate on cross functional project teams through all phases of the product development process including planning and product launch.


• Work with project core team to assist in defining user needs, generate design concepts and prototypes, and perform design evaluations (such as tolerance analysis, FEA, DOE, simulated use testing etc).


• Assist in the creation of product process validation plans and testing.


• Assist other design engineers, manufacturing engineering and suppliers to optimize designs for manufacturability, prototypes and process engineering change requests.


• Assignments will usually include one or more of the following:
  
  
  
  • Test of materials
  
  
  • Preparation of specifications, which include engineering drawings
  
  
  • Research investigations
  
  
  • Report preparation, including protocols, engineering reports, and design control documentation
  
  
  • Other activities of limited scope requiring knowledge of principles and techniques commonly employed in specific narrow areas of assignments
  
  
  • May be assisted by a draftsperson or technician
  
  
  
  

Qualification Requirements

Credentials/Experience:

• A minimum of a BA/BS in Engineering


• Demonstrated understanding of various types of mechanisms, materials, proper tolerancing, drafting standards, design for mold ability and GD&T are required


• Experience utilizing computer aided design (CAD) to develop a product is strongly desired

Knowledge, Skills, and Abilities:

• Medical device industry


• Project Management


• Three-Dimensional Parametric Solid Modeling


• FDA QSR and ISO 13485 quality standards


• Quality standards within the company


• Scheduling work to achieve goals


• Customer focused environment


• Strong organizational skills


• Strong verbal, written and presentation skills


• Problem solving , mechanical design, and statistical evaluation


• Process development and improvement


• Computer skills, including 3-D CAD , Word, Excel, and PowerPoint


• Familiarity with project management concepts


• Self-Motivated


• Managing a variety of assignments concurrently


• Be flexible and adapt to changes in work environment, requirements, and assignments


• Interface professionally and courteously with customers/public/internal staff


• Prioritize work


• Meet goals and objectives set for department and company


• Keep current in changing work methods and regulatory changes

Other Requirements

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

While performing the duties of this job, the employee could be required to stand.The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear.The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision, and ability to adjust focus.

Travel Requirements

Up to 5%

Americans with Disabilities Act (ADA):

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.