Previous Job
Previous
Engr 3, Mechanical
Ref No.: 18-27870
Location: Franklin Lakes, New Jersey
Start Date / End Date: 05/21/2018 to 05/21/2019
Company : Artech information Systems
Job Title: Engr 3, Mechanical
Job ID: CFNJP00019913
Location: Franklin Lakes,NJ
Duration: 12+Months

Job Description:
  • Mechanical Engineering is responsible for designing and developing components, mechanisms, systems and finished products or equipment.Demonstrates advanced knowledge of Mechanical Engineering and its application in solving moderately-complex mechanical problems. Demonstrates advanced understanding of internal and external customer or business needs.
  • Works independently to create design of multiple components, systems or devices. Independently tests, analyzes and solves advanced technical problems.
  • Applies advanced statistical techniques and utilizes design of experiments. Has in-depth experience, knowledge and skills in own job family.
  • Applies knowledge and skills to a wide range of standard and non-standard situations. Works independently with minimal guidance. Usually determines own work priorities.
  • Acts as a resource for colleagues with less experience.
  • The incumbent will join the Product Engineering team and will lead or contribute to the design, development and commercialization of medical device products.
Specifically, the Senior Engineer is expected to:
  • Provide deep technical expertise and engineering excellence to medical device product engineering projects.
  • Evaluate and support key products in terms of regulatory compliance and remediation activities.
  • Ensure appropriate design control strategy and document control processes are followed in completion of designated project activities.
  • Participate in executing technical and/or cross-functional project work and effectively manage an extended R&D team.
  • Manage project resources and forecast adjustments as necessary.
Responsibilities
  • Specific responsibilities will include the following as well as other duties, as assigned:
Product Engineering
  • Engineer robust and manufacturable products or improvements to existing products through strong understanding and application of engineering fundamentals.
  • Analyze design solutions using engineering first principles and advanced engineering methods, such as FEA.
  • Solve technical challenges drawing on a combination of experience, sound judgment, problem solving skills and advanced engineering methods.
  • Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis and data analysis.
  • Develop realistic and actionable design plans.
  • Develop design verification traceability matrices and associated requirements analysis.
  • Interface with key stakeholders from manufacturing plants.
  • Ensure compliance with Client quality policies, procedures and practices, as well as all local, state, federal and Client safety regulations, policies and procedures.
  • Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.
Leadership and Project management
  • Actively coach colleagues and teams, and encourage and facilitate continuous learning.
  • Demonstrate strong accountability for successful completion of designated tasks.
  • Effectively lead and direct the work of other engineers and laboratory technicians.
  • Proactively develop, maintain and share technical knowledge in specialized areas, remaining up-to-date on current trends and best practices.
Education and experience requirements
  • This position requires the following qualifications:
  • MS degree in Mechanical Engineering or Biomedical Engineering or closely related disciplines (Ph.D. preferred).
  • Minimum of 5 years post graduate experience as a product design / development engineer in the medical device or pharmaceutical industries (experience with FDA class II or III medical devices preferred).
  • Strong analytical and problem-solving skills with demonstrated capability of breaking down complex technical challenges to identify root cause and find innovative and robust solutions.
  • Demonstrated ability to formulate rationales with engineering justifications as appropriate.
  • Demonstrated experience with all phases of the Design Control process and understanding of disciplined product development process.
  • Expert understanding of management of design inputs and product requirements, including regulatory and quality requirements for medical products.
  • Preferred experience with plastic manufacturing/injection molding for medical devices in an FDA-regulated design control environment.
  • Experience in robust design verification strategy and execution, including worst-case conditions and utilization of FEA.
  • Proficiency with Minitab statistical software.
  • Proficiency and hands-on experience with advanced applications of DOEs.
  • Understanding of Critical Parameters Management.
  • Basic experience in SolidWorks or other equivalent 3-D CAD software.
  • Experience with Geometric Dimensions and Tolerances (GD&T).
  • Strong understanding of intellectual property considerations.
  • Excellent technical writing skills. Disciplined and well organized in documentation. Demonstrated ability to clearly and effectively communicate concepts.
Leadership and Project Management Experience
  • Experience leading global engineering teams of various experience level.
  • Experience with project initiation, planning, executing, tracking, closure and reporting.
  • Good understanding of medical device product development risk management methodologies.
  • Demonstrated ability to clearly and effectively communicate project plans, results and conclusions to management and cross-functional audience.
  • Proficiency with Microsoft Project or equivalent project planning software.

Thank And Regards

Sai Paramita
Lead Recruiter
Artech Information Systems LLC
360 Mt. Kemble, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3552 | Fax: 973.998.2599
Email:
Sai.Paramita@artechinfo.com | Website: www.artechinfo.com
Artech is the #1 Largest Women-Owned IT Staffing Company in the US!
Connect with us on - LinkedIn | Facebook | Twitter