Senior Engineer - Advanced Manufacturing Engineering

Purpose

We are seeking a Senior Advanced Manufacturing Engineer to support the design, implementation, and optimization of advanced manufacturing processes within the BVI Medical manufacturing environment for both new product introductions and lifecycle management (LCM) programs. This role may operate in either a leading or supporting capacity and will collaborate cross-functionally to integrate new technologies, improve internal processes, and coordinate with external partners and CMOs.

The role ensures compliance with applicable regulatory and quality standards (e.g., ISO, FDA CFR Part 820, MDR) across internal and external manufacturing processes, with the objective of improving quality, capacity, cost, and operational performance. This position operates within the R&D organization and requires a proactive, highly collaborative, team-oriented approach.

Key Responsibilities

• Support NPI by leading technical transfers from R&D to operations / production and executing the different activities related to NPI, VIPER initiatives, and or other formats for CC CC,ECO,(non) PPN,CDQ, or self-managed projects.
• Analyse existing manufacturing processes and product designs to identify opportunities for improving quality, cost and efficiency. Apply error-proofing (Poka-Yoke) and Design for Assembly (DFA) principles
• Identify and lead process improvement initiatives using Lean tools to eliminate waste (Kaizen). Collaborate with internal global stakeholders and external partners (suppliers and CMOs) to ensure alignment and successful technical transfers.
• Lead the development, validation, and implementation of robust manufacturing processes and technologies for new products and transfers.
• Participate actively in cross-functional and cross-regional teams to ensure seamless design transfer from R&D to manufacturing.
• Support or lead the specification, selection, installation, and qualification of equipment and tooling at global sites as required.
• Contribute to advanced manufacturing initiatives and capital investment projects across the global plant network.
• Provide technical support and training to regional and international teams.

Qualification

• Bachelor’s degree in mechanical, industrial, or manufacturing engineering or related field or by experience.
• Experience within the Life Sciences industry is required, with a strong preference for candidates from the Medical Devices sector.
• Available to work on-site in Vierpolders five days per week (full-time presence required)
• Fluent in Dutch and English; both written and spoken
• Strong multitasking abilities; able to manage various subjects and responsibilities simultaneously
• A collaborative team player with excellent communication skills
• 5 years of experience in a engineering role.
• Experiences with Lean methodologies.
• Proficient in CAD tools (e.g., SolidWorks), Smartsheet, and MS Office.
• Extensive knowledge of manufacturing and assembly processes and in process validation (IQ/OQ/PQ), risk management (dFMEA & pFMEA), and CAPA systems.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP.
• Ability in leading programs and teams for relevant subjects.

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