Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, or related field
Minimum 4 years of experience in the medical device sector, preferably spine/orthopedics
Proficient in 2D/3D CAD with Solidworks, Siemens NX, or equivalent
Knowledgeable in Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5
Experience coordinating prototype and production part manufacturing with vendors
Familiar with verification and validation processes for medical devices
Regulatory experience with FDA, EU/MDR, ISO, and related guidelines
Responsibilities
Lead and participate in project teams for medical device design and development
Develop and maintain Design History Files per client requirements
Interface with clients to define design objectives
Collaborate with stakeholders throughout the product development lifecycle
Work with quality, operations, and vendors to ensure products meet specifications
Compile and present project updates and technical presentations
Assist in solving complex engineering issues for clients
Benefits
Opportunity to engage in full lifecycle product development
Work in a collaborative environment with cross-functional teams
Exposure to a range of regulatory standards and quality assurance processes
Hands-on involvement with both design and project management aspects
Possibility of contributing to impactful medical solutions
Full Job Description
Description
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
Requirements
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.
