Job Description :
Product Design Engineer

Location: Franklin Lakes, NJ

Duration: FTE



Keywords: Mechanical/Manufacturing Engineering & Medical Devices, Disposable medical device design & development, manufacturing, Medical product sustenance,



Mandatory Skills:



             Product Design / product sustenance experience             

             8+ years of work experience. The individual in this position will have an extensive technical expertise and has full knowledge of other related disciplines. He/She develops technical solutions to complex problems which require the regular use of ingenuity and creativity

             Manufacturing process knowledge

             Knowledge on standards and regulatory requirements for various regions

             Fixture development & selection

             Technical (report) writing

             Basic Mechanical Engineering

             Disposable device development

             Change control Management

             NC/CAPA             Knowledge

             Design verification

             Plastic component design & Injection molding process

             Tolerance analysis

             Sheet metal component design

             ISO 13485 / FDA Guidelines

             GD&T

             Prototyping

             Solid works

             Communication



Desired Skills: Leadership, Project Management, Coordination, Learnability



Responsibilities:



             Guides the successful completion of major programs and may function in project leadership role.

             Represents the organization as the prime technical contact on contracts and projects.

             Independently determines and develops approach to solutions.

             Supports material/design/process changes to the product line through design control process, with well-documented research/analyses.

             Develops technical solutions to complex problems using sound engineering principles, utilizing experimental, computational and analytical methods.

             Applies innovative & logical risk based approach to product development challenges with the capacity for original thinking.

             Designs and develops in vivo and in vitro models to evaluate product features & improvements.

             Writes implements and leads bench studies, tolerance stack up analysis, design verification, validation, vendor interactions, materials specifications and component specifications.

             Collects, records, reports, interprets and analyzes data, presents results to peers and business leadership.

             Provides advanced engineering skills and product evaluation support to the platform toward building business cases for new opportunities.



Core Skills:



             Strong technical judgment and extensive technical leadership skills.

             Demonstrated capability of leading R&D product development projects.

             Experience in guiding team/individuals to develop technical solutions to complex problems.

             Sound knowledge of engineering first principles.

             R&D functional planning, requirement generation and technical (DFSS/Design/Cross functional) reviews for all product development phases.

             Strong project management, prioritizing and multi-tasking skills to work within tight deadlines.

             Proficient in solid modeling (Pro/E,  SolidWorks or equivalent)

             Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.

             Experience in directing associates and leading small cross-functional groups is required. 

             Proficient in Microsoft Project.

             Disciplined phase-gate product development processes & project planning.

             Proficiency with fixture design including basic machining considerations and developing test methods.

             Understanding of Measurement Systems Analysis (MSA

             Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies.

             Product development considerations for tightly controlled, high-volume manufacturing process.

             Strong creative, analytical and problem solving skills required.

             Good written & verbal communication skills.