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Senior Mechanical Engineer Columbia Tech (Corporate Office)

Senior Mechanical Engineer

Full Time • Columbia Tech (Corporate Office)

Description:

 As a member of the engineering services team, the Senior Mechanical Engineer will solve complex problems and participate in the specification, design, prototyping and testing of a diverse range of tooling, fixtures, design for manufacturability projects, and other customer product design needs. Under the direction of the Senior Vice President of Engineering, the engineer in this role will be performing design tasks of a complex technical nature requiring investigation of new technologies and applying engineering design principles and practices.

Responsibilities: 

With guidance, and at all times following the Cogmedix Design Controls compliant process and 21 CFR 820.30, define mechanical engineering design requirements and develop specifications in accordance with customer expectations and requirements.

Design and model mechanical, fluidic, and thermal systems within, and associated with, electro-mechanical/optical/fluidic medical devices and supporting assembly and test tooling/fixtures.

Create mechanical engineering drawings utilizing Geometric Dimensioning and Tolerancing principles in accordance with current industry standards.

Create and refine technical mechanical part and assembly drawings/models to accurately capture design intent.

Create and refine moderate complexity mechanical components, including sourcing and volume models.

Manage electrical parts as typically used in mechanical design models.  This includes PCBAs, connectors, plugs, and layout control models.  

Create and maintain bill of materials.

Prepare and complete engineering change order packages. 

Build, troubleshoot, verify and validate engineering prototypes against specifications.

Contribute to risk assessment of mechanical and system design, including generation of FMEAs. 

Prepare and release required design documentation to support release to customer for review.
 
Provide support for existing products in production as required.

Identify and analyze design problems to achieve optimal solutions that satisfy cost and technical requirements using both internal and external technical resources. 

Formulate new, innovative approaches to solve technical challenges.

Create and communicate project tasks and deliverables, and manage time to meet project deadlines and costs. This includes reporting pertinent information at key milestones through clear, concise oral and written communications with customers and internally.

Performs other duties as required.

Essential Requirements: 

Positive attitude, self-motivator, and tenacious follow up required.

Superior customer service attitude.

Excellent teamwork, communication, and interpersonal skills.  

Strong electro-mechanical orientation required.

Experience in cGMP organizations preferred.

Direct experience working in an ISO regulated environment.  ISO 13485 certified preferred.

Ability to create, design and solve engineering problems with assistance from more senior staff.

Demonstrated ability to decompose engineering challenges into actionable task lists.

Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.

2-6 years of design/development experience. 

Bachelor’s degree in Mechanical Engineering required.

Ability to thrive in a fast-paced team setting with engineers, technicians, and manufacturing personnel.

Basic skills in MS Office applications and SolidWorks required.  

Knowledge of Solidworks PDM is a benefit.

Basic working knowledge of mechanical fabrication practices, such as machining, sheet metal, welding and plastics fabrication.

Some experience with ERP/MRP and Data Management systems for documentation revision control preferred. Omnify PLM experience beneficial.

Columbia Tech is an Equal Opportunity Employer. Columbia Tech does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.





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