Manufacturing Systems Engineer - Capital Equipment

Purpose

As a Manufacturing Systems Engineer, you will lead Operations activities for new technologies and platforms within the capital equipment division. You will play a critical role in industrializing advanced electro‑mechanical systems—developing, validating, and scaling manufacturing solutions that position our products at the forefront of the industry.

Working in a dynamic international environment, you will collaborate with global technical partners and cross‑functional teams to build the manufacturing foundation for the BVI capital equipment portfolio. You will also support lifecycle initiatives aimed at enhancing quality, expanding capacity, and improving cost efficiency across existing platforms.

Key Responsibilities

• Lead international New Product Introduction (NPI) projects, providing technical and operational leadership.
• Provide systems engineering support for corporate and cross‑functional initiatives.
• Serve as a core Operations team member in new product development, partnering with Manufacturing, Supply Chain, Sourcing, and R&D to develop and execute robust industrialization plans.
• Introduce, implement, and validate new manufacturing technologies, including capital investment and capacity planning.
• Oversee design controls–related operations documentation (plans, protocols, reports, test methods, work instructions, PFMEAs, control plans) and contribute to global regulatory submissions.
• Act as the Voice of Operations throughout the design cycle by leading Design for Excellence (DfX) reviews and ensuring alignment with lean manufacturing principles prior to design freeze.
• Partner closely with R&D to ensure manufacturing infrastructure supports product design, project milestones, and business objectives.
• Conduct process studies to identify and implement improvements in quality, efficiency, and scalability.
• Support lifecycle management initiatives to optimize manufacturing performance across the product portfolio.

Qualification

• Master’s degree in Engineering (Electrical, Biomedical, Mechanical, or related discipline) with 3+ years of relevant experience, or an equivalent combination of education and experience.
• Experience in a highly regulated industry; medical device experience strongly preferred.
• Understanding of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 (or comparable regulatory frameworks).
• Expertise in process design, development, and manufacturing systems implementation.
• Strong engineering problem‑solving and analytical skills, with the ability to make sound decisions based on data—even when incomplete.
• Knowledge of electrical wiring design and manufacturing, including connections and integration.
• Understanding of PCBA design, manufacturing, and testing.
• Experience managing electronics development (multiple ECAD platforms considered a plus).
• Hands‑on experience with prototyping, development, and acceptance testing.
• High‑level proficiency in mechanical design tools (SolidWorks and/or Solid Edge).
• Ability to assess and mitigate product and project risks.
• Demonstrated ability to influence cross‑functional and international stakeholders without direct authority.
• Excellent communication skills and ability to tailor messaging to technical and non‑technical audiences.
• Fluent English.

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

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