Wilmington-Clinton County Chamber of Commerce

Engineering Manager

Ferno-Washington, Inc.
Job Description
The Engineering Manager is responsible for all new product development and continuous improvement activity. Works closely with functional leaders of Ferno Group Companies, Contract Engineering Firms, and Contract Manufacturers to achieve objectives.  Serves as key member of the interdisciplinary team to include product management, marketing, sales, finance, manufacturing, procurement, operations, regulatory, and quality to drive business growth.
 
ESSENTIAL FUNCTIONS:
 
  • Provide technical direction and guidance, as well as hands-on project management, for all product development, continuous improvement, testing, and technical writing functions
  • Drive implementation of formal processes to support the product development and NPI effort to increase speed to market
 
  • Responsible for meeting process controls and requirements for all activities within prescribed area per FDA 21 CFR 820 and ISO 13485.
 
  • Participate in FDA/ISO Audits as appropriate
 
  • Ensure the optimal application of technology and engineering resources to meet or exceed customer and commercial requirements per product requirement specification(s)
  • Influence, monitor, and drive new product development and NPI activity across Ferno Group companies, Contract Engineering firms, and Contract Manufacturers to leverage resources, drive operational efficiency, reduce cost, and increase speed to market
  • Establish and manage team objectives, initiatives and accomplishments
  • Responsible for primary hiring, on-time performance appraisals, coaching/counseling, employee development, employee engagement, and necessary communications regarding employee performance
  • Develop annual operating budget for assigned programs, provide status reports and other related communications on monthly basis
  • Responsible for projects being completed on time and within budget
  • Provide technical expertise to engineers in the area of design best practice, failure modes, failure analysis, and test requirements
 
 
 
QUALIFICATIONS:
 
  • Undergraduate degree in Engineering, MS/MBA preferred
  • Minimum of seven years of experience working as an engineer on successful product development programs in medical device field
  • Minimum of three years of engineering management responsibility in medical device field
  • Complete understanding of FDA 21 CFR 820 and ISO 13485 process controls and requirements
  • Demonstrated product design transfer (NPI) proficiency on successful new product introductions, Upstream Manufacturing Engineering experience a plus
  • Ability to make decisions impacting team members regarding training, coaching/counseling and appropriate follow-up
  • Ability to make decisions in regard to compliance, product reliability, and analysis of testing methodologies
  • Strong operational and project management skills
  • Demonstrated team building and leadership skills
  • Systems integration, metal fabrication, electro-mechanical, and hydraulic experience required
 
 
PHYSICAL/SAFETY REQUIREMENTS:
 
  • Job demands include prolonged sitting, may need to stoop, bend and stand as appropriate
  • Requires coordination of hands and/or eye/hand/foot
  • Meets cognitive demands to include visual discrimination/memory, auditory discrimination/memory reading ability, independent decision making and retention of specific knowledge
  • Requires use of safety glasses in designated areas
Contact Information