Mechanical Design Engineer

Ferno; Wilmington (OH); On-site; USD 85,000 - 110,000; Full time

Job summary

Ferno in Wilmington, Ohio, seeks an experienced Mechanical/Biomedical Engineer to lead the design of electro-mechanical EMS systems. You will collaborate with NPD, Innovation, Test, Quality, and Product Management to advance product lines and sustain documentation throughout the life cycle.

The role requires a strong background in GD&T, DFMA, and SolidWorks, with experience in FDA-regulated environments and high-volume EMS products. This position is on-site in Wilmington, OH.

Qualifications

• B.S. in Mechanical or Biomedical Engineering with 4+ years related experience.
• Experience with FDA-regulated devices or regulated environments.
• Experience designing mid-to-high-volume EMS products.

Responsibilities

• Engineer electro-mechanical EMS product designs and subsystems.
• Perform design reviews, FMEA, and maintain design history files.
• Ensure documentation release and post-release support.
• Develop BOMs and implement design changes with cross-functional teams.
• Coordinate with manufacturing, test, quality, and regulatory.

Skills

Finite Element Analysis

Cross-functional collaboration

Design reviews

Root cause analysis

Failure analysis

Regulatory awareness

Education

B.S. in Mechanical or Biomedical Engineering

Tools

SolidWorks

CAD software

Job description

Description

Summary of Role:

Responsible for engineering issues related to design of electro-mechanical EMS systems including all structural and mechanical components and sub-systems utilized in Ferno’s product line. This position will work closely with NPD, Innovation, Test, Quality, Product Management, Finance and Operation teams in Wilmington, Ohio.

Essential Duties and Responsibilities include the following:

• Engineering design support of electro-mechanical products and subsystems.
• Familiar with Finite Element Analysis, FEA.
• Participate in new product development programs as both a voice of the user and reliability champion. Participate in design reviews, FMEA development, and review / approve design history file documentation.
• Ensure product and component documentation is complete prior to release. Maintain product documentation throughout post-release product life-cycle. e.g. DFMEAs during Failure or root cause analysis.
• Review product verification and validation test plans and results. Provide feedback to development teams.
• Evaluate new products and recommend post release support plans.
• Create, maintain and update BOMs as required.
• Develop and implement incremental improvements to existing product base.
• Work with test engineering, quality and regulatory to ensure products maintain certification to various standards.
• Provide issue escalation support to internal and external customers.
• Investigate customer complaints and field issues. Conduct failure analysis (FA) as well as identify and implement corrective actions. Must be able to manage a small cross-functional team to ensure corrective actions are fully implemented.
• Maintain and update design drawings and models utilizing Solidworks.
• Utilize proper GD&T on product drawings created.
• Conduct design reviews for updated or new designs.
• Work with test engineering and quality to make sure there is an adequate test plan and proper verification and validation is performed on all updated or new designs.
• Use root cause analysis tools such as C&E matrix (fish bone), 5 why’s etc. to properly document and define issue related to legacy or new product
• Collaborate with manufacturing and quality engineers to identify cost improvement ideas as they relate to product design.
• Other duties may be assigned.

Education and/or Experience

• B.S. degree in Mechanical or Biomedical Engineering and 4+ years of related experience.
• And/or training; or equivalent combination of education and experience.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Knowledge and experience of application and use of GD&T
• Knowledge and experience of application of Design for Manufacturability and Assembly
• Experience with FDA regulated devices or experience working in a regulated industry
• Experience developing and/or supporting medium to high volume products, preferably for EMS applications
• Knowledge of utilizing Solidworks or an equivalent 3D modeling CAD software

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.