Purpose

Responsible for the design and development of consumable products for ophthalmic surgical devices

Key Responsibilities

• Design and develop medical device consumables per DfX as well as associated test and fabrication fixtures
• Define test methods and conduct testing.
• Interface with internal and external suppliers, manufacturers, and customers
• Generate detailed part and assembly drawings while applying GD&T techniques and perform tolerance analysis of assemblies
• Work collaboratively with project teams (e.g., Quality, Regulatory, Manufacturing, and Service) at all stages of development and through product lifecycle.
• Support of Quality teams in ensuring GxP and other activities (e.g., complaints root causing and resolution)
• Support of Regulatory team with technical documentation as mandated by authorities
• Effectively communicate activity status, issues and mitigation plans with key stakeholders
• Other duties as required
  
  

Qualification

Minimum Required Education And Experience

• Must work onsite in Vierpolders, NL
• Bachelor's degree in Industrial Design Engineering, or related field, Advanced Degree or MBA preferred.
• 5 years’ relevant experience in the medical device industry (Consumables preferred); or equivalent combination of education, training and experience
• Experience leveraging rapid prototyping materials and technologies for fast prototype build and design iteration
• Knowledge of applicable materials, manufacturing methods and engineering industry standards and specifications
• Knowledge of plastic part design and materials for high volume part production
• Result orientated with the ability to plan and deliver against project deadlines
• Experience working on cross functional project teams in the end-to-end lifecycle, bringing new products/technologies from concept through commercialization
• Experience operating in regulated design controls environment with knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices (e.g., FDA, MDR, 13485 etc.)
  
  

Other Requirements

• Excellent knowledge of spoken and written Dutch and English
• May require travel up to 5%.
  
  

Company

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com