Essential Responsibilities:

Leads and/or participates in project teams for the design and development of medical devices.
Develops and maintains Design History Files in accordance with client procedures and regulations
Interfaces with clients to define and achieve design objectives
Proactively works with all parties throughout the product development lifecycle to successfully achieve milestones
Interfaces with quality, operations, and external vendors to ensure manufactured products meet design intent
Compiles, prepares, and presents information for project updates and technical presentations
Assists in resolving complex engineering problems and providing sound solutions to clients

Qualifications:

Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or similar discipline
Minimum 4 years of related work experience in the medical device industry (spine/orthopedic experience preferred)
Extensive 2D/3D CAD design experience in Solidworks, Siemens NX, or similar software
Experience with Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 and designing components for manufacturability
Ability to coordinate the manufacturing of design prototypes and production parts with external vendors
Familiarity with verification and validation testing of medical devices
FEA (Finite Element Analysis) experience a plus
Experience designing products in a regulated environment including FDA, EU/MDR, ISO, and other relevant regulations
Understanding of the phases of medical device development in accordance with regulations and industry standard practices
Excellent interpersonal and written communication skills
Ability to multitask and efficiently manage multiple projects
Candidate must be a self-starter, self-motivated, and results-oriented
Able to work both independently and have with cross-functional teams
Extensive project management skills with the ability to work against tight timelines

This position will involve all aspects of product design and project management including, but not limited to, client consultation, vendor selection and management, marketing support, and post-market surveillance.

We are currently seeking a self-motivated, charismatic individual to join our product development engineering team. A successful candidate for this position possesses exceptional technical skills and understanding related to working in the highly regulated medical device industry. This individual will have direct support from leadership and team members through training and continuous learning. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package. If you ’re looking for an autonomous career opportunity while working in a transparent and positive culture that promotes professional growth and teamwork, we’d love to hear from you!

Benefits of Employment:

Competitive Base Salary plus Bonus potential
Benefits: Medical, Dental, Vision, Life Insurance, 401(k) match, generous PTO, 12 Paid Holidays, Wellness Program with Fitness Center and Training Classes, Flexible Schedule, remote work from home days
Company cell phone and laptop
Training and support in developing your understanding of medical device development, regulatory affairs, and quality management systems
Exciting, fast-paced, and team-oriented culture with fun company outings and team building activities
Great opportunity to get in on a growing, enthusiastic company and establish yourself as a long-term key member

Jalex Medical

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