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Job Openings >> Senior Engineer
Senior Engineer
Summary
Title:Senior Engineer
ID:1229
Department:Engineering
Location:Colorado Springs, CO
Description

Position Summary:

Technical engineering lead responsible for design, manufacturing development and transferring new products to Production. Directs and coordinates engineering activities for multiple development projects. Typically reports to Engineering Management or Project Team Leader. May supervise other Engineers and Technicians.


Position Responsibilities:

  • Follow all employee guidelines and Quality Systems Regulations (QSR's) as defined by BMED's practices, policies and Standard Operating Procedures (SOP's) to insure that customer requirements and FDA (or equivalent) regulations are met.
  • Designs products or systems such as surgical devices, mechanisms, fixtures and injection molded components.
  • Plans and directs personnel in fabrication of prototypes, first articles, test equipment, and development methods and procedures for manufacturing and testing products or systems.
  • Facilitates reviews and executes test protocols and set-up of necessary methods to validate initial design and process selections.
  • Creates project development plans, product specifications, conceptual designs and manufacturing concepts.
  • Selects materials based on customer requirements and BMED’s capabilities.
  • Provides design, process and material related input related to products and manufacturing processes.
  • Generates Test Reports, Drawings, Procedures, Routers, Specs, DCO’s, ECO’s and other Technical Reports.
  • Creates, reviews and updates Manufacturing Assembly Instructions.
  • Creates Component and Process Qualification documents including Components Requirements Reviews (CRRs), Manufacturing Equipment, Assembly Fixture and Test Fixture qualification requirements (IQ, OQ, PQ).
  • Facilitates initial tooling trials. Troubleshoots tooling performance, process performance, design and material related issues during manufacturing start up.
  • Facilitates or performs process characterization (DOE) and process validation on components/products according to BMED’s procedures and/or customer requirements.
  • Provides quotation for potential new products, which include selection of correct materials, processes, tooling and equipment.
  • Participates/leads various project teams and conference calls while representing BMED to the customer.
  • Develops appropriate vendor contacts, approves prototype raw materials and assists in vendor certification.
  • Trains, mentors other Engineers and Technicians.
  • Other duties as assigned.


Qualifications

Minimum:

  • Bachelors Degree in Engineering with a minimum of 5 years engineering experience in a product development or manufacturing environment.
  • Successful experience in a technical leadership role.
  • Experience working in a highly regulated environment.
  • Ability to plan activities, work independently and complete work on schedule.
  • Skilled in writing protocols, reports and engineering change orders.
  • Experience with equipment and/or process qualifications and validations (IQ, OQ, PQ).
  • Skilled in CAD and designing parts, component assemblies, and fixtures.
  • Solid interpersonal and communication skills and the ability to work in a team environment.
  • Strong problem solving skills and efficient management of time and resources.

Preferred:

  • Advanced degree in Engineering.
  • Experience with plastic injection mold tooling and processing.
  • Medical Device Industry experience.
  • Experience with quality standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 11.
  • Experience designing and conducting DOEs using MiniTab.
Great benefits offered including medical, dental, 401K, education assistance, and more!

Biomedical Innovations is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Biomedical Innovations will provide reasonable accommodations for qualified individuals with disabilities.

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