Careers

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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