Careers

ConceptDesign & DevelopmentVerification and ValidationRegulatoryQMSProduct Launch

JALEX Medical is a consulting firm that provides engineering, quality, and regulatory services to the medical industry. We are always looking for talented mechanical engineers, biomedical engineers, and quality and regulatory specialists with a passion to work in a fast-paced, exciting environment.

Open Positions

Design Engineer

Qualifications:

  • Bachelors Degree in Mechanical Engineering or similar discipline
  • Minimum 3-5 years experience with Medical Device Development in the medical industry
  • Extensive 2D/3D CAD design experience, including expertise in Geometric Dimensioning and Tolerancing (GD&T) and design for manufacturability
  • Ability to coordinate the manufacturing of design prototypes and production parts
  • FEA (Finite Element Analysis) experience a plus
  • Experience designing products in a regulated environment including FDA, ISO and other regulations
  • Understand and navigate through the multiple phases of product development
  • Must have excellent communication dealing with staff, customers, and suppliers
  • Ability to simultaneously manage multiple projects efficiently
  • Candidate must be a self-starter, self-motivated, and results oriented
  • Must be able to work independently and have ability to work with cross-functional teams
  • Extensive project management skills with the ability to work under tight timelines and multi-task

Responsibilities:

  • Project leader for the design and development of medical devices
  • Interface with customers and distributors to define and achieve design objectives
  • Interface with quality, operations and vendors to ensure manufactured products meet design intent
  • Maintain device history files per FDA, ISO and other regulations
  • Compile, prepare and present information for project updates and technical presentations
  • Assist in resolving complex engineering problems and provide sound solutions to customers

Regulatory and Quality Systems Specialist

Qualifications:

  • Bachelor’s Degree in Engineering, Science, or health-related field
  • 3-5 years related work experience
  • Working knowledge of FDA and other regulatory authorities
  • FDA Regulatory submission experience (510ks, PMAs, IDEs)
  • Quality Systems development, implementation, and training experience
  • International submission experience (CE Mark, MDL, MDEL)
  • Experience with ISO 13485, FDA, MDD (EU Medical Device Directive), and CMDD (Canadian
  • Directive) compliance requirements and training
  • Experience with Risk Management per ISO 14971
  • Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls a plus
  • Candidate must be a self-starter, self-motivated, and results oriented
  • Excellent interpersonal and written communication skills
  • Must be able to work independently and have ability to work with cross-functional teams
  • Extensive project management skills with the ability to work under tight timelines and able to multi-task

Responsibilities:

  • Assist with premarket FDA and international regulatory submissions
  • Assist with development and/or revision of Quality System procedures and processes
  • Assist with internal and supplier audit development, implementation, and execution
  • Serve as a company representative during external audits by Regulatory and Third Party Auditors
  • Design Control documentation assistance
  • Validation and Testing Protocol Development
  • Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements

Apply Today!

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