Engineering Manager

1 month ago

Wilmington, United States Ferno Washington Inc Full time
Job DescriptionJob DescriptionDescription:

The Senior Engineering Manager is responsible for leading the effort of sustaining engineering activity and may be responsible for new product development projects. 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.


Requirements:

ESSENTIAL FUNCTIONS:

  • Provide technical direction and guidance, as well as hands-on project management, for sustaining engineering, product development, continuous improvement, testing, and technical writing functions
  • Drive implementation of formal processes to support the sustaining product development, and NPI efforts
  • 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). Responsible for authorship of these specification(s).
  • Influence, monitor, and drive engineering activity within FERNO Wilmington Engineering, 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
  • Assist in developing 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 electro-mechanical design best practice, CAD modeling, engineering drawings and specifications, failure modes, failure analysis, and test requirements. Understanding of tolerance stack ups and GD&T. Experience with FEA using Solidworks. Ability to calculate basic strength of materials properties.
  • Sole responsibility for engineering documentation and drawings enabling release of electromechanical components and assemblies for production using Altium and Solidworks
  • Responsible for meeting process controls and requirements for all activities within prescribed area
  • Systems integration, metal fabrication, electro-mechanical, and hydraulic familiarity required. Familiarity or ability to learn PCB design, layout, embedded firmware, harnesses, switches and sensors, wireless communications, ST and PIC microcontrollers, LCD screens, sheet metal, extrusions, castings, injection molds, CNC milling and lathing, lithium ion batteries, brushed and brushless DC motor systems, finishing processes such as anodization, powdercoat, and zinc-plating, metallurgy and heat treatment.
  • Strong operational and project management skills
  • Familiarity with industry standards such as IEC, UL, UN, CSA, CE, and EN

QUALIFICATIONS:

  • Undergraduate degree in Engineering, master's degree preferred
  • Minimum of ten years of experience working as an engineer on successful engineering 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 analyses of testing methodologies
  • Demonstrated team building and leadership skills

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


Ferno is an equal opportunity employer and that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.

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