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Staff R&D Engineer

Katalyst Healthcares & Life Sciences

Franklin Lakes, NJ

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JOB DETAILS
SKILLS
Analysis Skills, Audio Engineering, Business Case, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Code of Federal Regulations, Creo Elements/Pro, Customer Experience, Data Analysis, Design Verification, Design for Six Sigma (DFSS), Engineering, Experiment Design, FDA (Food and Drug Administration), Healthcare, ISO (International Organization for Standardization), Leadership, Machining, Maintain Compliance, Medical Equipment, Minitab, Orthopedics, Product Design, Product Development, Product Engineering, Product Programs, Product Support, Product Testing, Quality Assurance, Quality Assurance Methodology, Research & Development (R&D), Risk, SolidWorks, Statistics, Systems Analysis, Test Design, Test Fixtures, Test Plan/Schedule, Time Management, Tolerance Analysis, United States Department of Energy (DOE), Validation Testing
LOCATION
Franklin Lakes, NJ
POSTED
30+ days ago
Roles & Responsibilities:
  • Serve as R&D Lead on New product development and product engineering initiatives focused on changes to existing products and design changes.
  • Guides the successful completion of major programs and may function in project leadership role.
  • Independently determines and develops approach to solutions.
  • Represents the organization as the prime technical contact on contracts and projects.
  • Supports material/design/process changes to the product line through design control process, with well-documented research/analyses.
  • Demonstrates accountability for successful and timely completion of designated tasks.
  • Develops technical solutions to complex problems using sound engineering principles, utilizing experimental, computational and analytical methods.
  • Designs and develops in vivo and in vitro models to evaluate product features & improvements.
  • Applies innovative & logical risk based approach to product development challenges with the capacity for original thinking.
  • Develops robust test methods, design test fixtures and execute measurement system analysis.
  • Ensures compliance with Client quality policies, procedures, and practices through appropriate communication, training and education of sound quality assurance principles.
  • Plans, executes and analyzes design of experiments (DOE).
  • Writes implements and leads bench studies, tolerance stack up analysis, design verification, validation, vendor interactions, materials specifications and component specifications.
  • Performs data analysis using statistical tools, regression analyses and develop transfer functions.
  • 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.
Requirements:
  • 7+ year experience in R&D/Product Development Engineering.
  • Medical Device experience with all aspects of Design Controls (FDA 21 CFR 820.30 / ISO 13485).
  • Proficiency with fixture design including basic machining considerations and developing test methods.
  • Understanding of Measurement Systems Analysis (MSA) and DFSS (design for six sigma).
  • Experience with Minitab for Statistical Analysis.
  • Proficiency in CAD, Pro/E, SolidWorks.
Plus:
  • Previous Client experience.
  • Orthopaedic Med Device specific experience (Stryker, Client, Client Biomet, Healthcare).

About the Company

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Katalyst Healthcares & Life Sciences