Job Description
Job Description
Fiagon NA LLC is an established, high growth medical manufacturing company that is committed to developing and marketing innovative technologies for the rapidly changing demands of the global medical industry. We seek to help patients by creating products specifically designed to facilitate safer procedures and improved patient outcomes. We are looking for a gumptious engineer that will work with our dynamic Team where innovation isn’t just a buzzword!
The Process Engineer will play a key role in the design, development and clinical evaluation of innovative medical devices. This role combines hands-on product engineering with significant clinical and customer interaction, requiring approximately 50% travel to hospitals, clinical sites, and customer facilities.
The ideal candidate is an engineer who is ready to unleash their superpowers! One who is both technically strong and comfortable in the clinical environment capable of engaging directly with physicians and OR staff to observe product use, collect feedback, and translate insights into design improvements. This position is ideal for someone who thrives at the intersection of engineering, clinical performance, and customer experience.
RESPONSIBILITIES
Product Development & Engineering
- Work with team members in Product Management, R&D, Quality, Regulatory, and Operations to lead the execution of new development efforts.
- Manage execution of projects to a schedule and product development process including development phase reviews.
- Lead or support design and development of new medical devices from concept through commercialization.
- Understand the company Quality Management System (QMS) and follow the company procedures, policies, and methodologies for product development.
- Develop prototypes, perform design verification/validation (V&V), and support design transfer to manufacturing.
- Conduct root-cause analysis and continuous improvement on existing products.
- Proactively communicate project status in terms of cost, schedule, performance, issues, open risk, and action plan for meeting project goals.
- Facilitate productivity by ensuring continued communication and alignment throughout the team.
Clinical & Customer Support (≈50%)
- Provide on-site technical support during clinical evaluations, product demos, and early commercial use.
- Observe clinical procedures to understand workflow and gather actionable feedback for design improvement.
- Develop and implement best practices to assure successful procedural outcomes with customers
- Serve as a key liaison between engineering, clinical teams, and customers to ensure successful product adoption.
- Support physician training, product troubleshooting, and technical presentations as needed.
- Document field feedback and translate it into structured product requirements and design inputs.
- Ability to travel at least 50% of the time.
Cross-Functional Collaboration
- Partner closely with Clinical, Marketing, and Sales teams to align engineering activities with customer needs.
- Communicate findings from field activities to internal design and leadership teams.
- Participate in design reviews, project planning, and strategy sessions for next-generation products.
REQUIREMENTS:
- Minimum of a Bachelor’s degree in Electrical Engineering, Mechanical, Software or Biomedical field.
- 4+ years’ of experience in medical device product development or field-based technical engineering role.
- Background in engineering or medical devices preferred.
- Experience in Ear, Nose, and Throat medical industry is optimal.
- Experience and understanding of the design process for medical devices.
- Good understanding of FDA guidelines and requirements for medical devices.
- Self-motivated, adaptable, and able to work independently in a fast-paced environment with high attention to detail.
Company DescriptionFiagon NA, LLC, believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives.
Company Description
Fiagon NA, LLC, believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives.