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:
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Bachelors Degree in Mechanical Engineering or similar discipline
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Minimum 3-5 years experience with Medical Device Development in the medical industry
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Extensive 2D/3D CAD design experience, including expertise in Geometric Dimensioning and Tolerancing (GD&T) and design for manufacturability
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Ability to coordinate the manufacturing of design prototypes and production parts
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FEA (Finite Element Analysis) experience a plus
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Experience designing products in a regulated environment including FDA, ISO and other regulations
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Understand and navigate through the multiple phases of product development
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Must have excellent communication dealing with staff, customers, and suppliers
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Ability to simultaneously manage multiple projects efficiently
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Candidate must be a self-starter, self-motivated, and results oriented
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Must be able to work independently and have ability to work with cross-functional teams
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Extensive project management skills with the ability to work under tight timelines and multi-task
Responsibilities:
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Project leader for the design and development of medical devices
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Interface with customers and distributors to define and achieve design objectives
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Interface with quality, operations and vendors to ensure manufactured products meet design intent
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Maintain device history files per FDA, ISO and other regulations
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Compile, prepare and present information for project updates and technical presentations
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Assist in resolving complex engineering problems and provide sound solutions to customers
Regulatory and Quality Systems Specialist
Qualifications:
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Bachelor’s Degree in Engineering, Science, or health-related field
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3-5 years related work experience
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Working knowledge of FDA and other regulatory authorities
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FDA Regulatory submission experience (510ks, PMAs, IDEs)
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Quality Systems development, implementation, and training experience
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International submission experience (CE Mark, MDL, MDEL)
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Experience with ISO 13485, FDA, MDD (EU Medical Device Directive), and CMDD (Canadian
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Directive) compliance requirements and training
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Experience with Risk Management per ISO 14971
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Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls a plus
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Candidate must be a self-starter, self-motivated, and results oriented
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Excellent interpersonal and written communication skills
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Must be able to work independently and have ability to work with cross-functional teams
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Extensive project management skills with the ability to work under tight timelines and able to multi-task
Responsibilities:
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Assist with premarket FDA and international regulatory submissions
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Assist with development and/or revision of Quality System procedures and processes
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Assist with internal and supplier audit development, implementation, and execution
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Serve as a company representative during external audits by Regulatory and Third Party Auditors
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Design Control documentation assistance
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Validation and Testing Protocol Development
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Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements