Careers

JALEX Medical is a consulting firm that provides engineering, quality, and regulatory services to the medical industry. We work with clients around the world to bring their medical device ideas from concept to market. Our engineers are trained to understand all facets of product development and provide services throughout each phase of a product’s life cycle. From design through to commercialization.

Design Engineer

Qualifications:

•    Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or similar discipline 
•    Minimum 7-9 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 able to multi-task

Responsibilities:
•    Project leader for the design and development of medical devices
•    Interface with clients and distributors to define and achieve design objectives
•    Interface with quality, operations and vendors to ensure manufactured products meet design intent 
•    Create and 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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