Senior Engineer, Advanced Manufacturing Engineering

Purpose

The Senior AME Engineer serves as the lead Operations representative on new product development and introduction (NPI) projects. In this role, you will be responsible for the design and development of manufacturing processes for capital equipment and cutting-edge electromechanical medical devices. You will drive process validation activities and deliver critical operational milestones to ensure products are successfully brought to market with robust, scalable manufacturing processes and optimized cost structures. The Senior AME Engineer also leads or supports lifecycle management initiatives focused on improving quality, capacity, and cost efficiency across existing product lines.

Key Responsibilities

• Act as the Operations leader for local and global NPI projects and sustaining initiatives.
• Provide electromechanical engineering leadership to corporate and international programs.
• Serve as a core Operations team member within product development, integrating Manufacturing, Supply Chain, Sourcing, and cross-functional input to build and execute optimal operational strategies.
• Lead process design (equipment and tooling), development, validation (IQ/OQ/PQ), and capital and capacity planning.
• Own and oversee design controls–related operations documentation, including plans, protocols, reports, test methods, work instructions, PFMEAs, and control plans; contribute to global regulatory submissions.
• Serve as the Voice of Operations throughout the design cycle by leading Design for Excellence (DfX) reviews (manufacturing, service, test, etc.) and ensuring feedback is incorporated before design freeze.
• Drive the application of lean manufacturing principles and operational excellence from concept through industrialization and beyond.
• Ensure alignment with cost of goods sold (COGS) targets and proactively resolve operational variances within the design cycle.
• Partner closely with R&D to ensure manufacturing infrastructure supports product design, project milestones, and business objectives.
• Design and execute process studies to identify and implement manufacturing improvements.
• Collaborate effectively with external contract manufacturers to support development, transfer, and production readiness.
• Support lifecycle management initiatives focused on quality improvement, capacity expansion, and cost optimization.

Qualification

• Bachelor’s degree with 7+ years of relevant experience, or Master’s degree with 5+ years of relevant experience (or an equivalent combination of education and experience).
• Experience in a highly regulated industry; medical device experience strongly preferred.
• Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 (or comparable regulatory frameworks).
• Proven expertise in process design, development, and validation (including IQ/OQ/PQ).
• Experience supporting complex electromechanical products, ideally across medical device platforms including capital equipment and consumables.
• Hands‑on experience working with external contract manufacturers.
• Proficiency in mechanical design tools ("SolidWorks" and/or "Solid Edge"; experience with both preferred).
• Experience with electronic design tools ("Altium" preferred).
• Knowledge of optics technologies and related devices.
• Strong analytical and engineering problem‑solving skills, with the ability to make sound decisions based on data, even when incomplete.
• Ability to assess and mitigate product and project risks.
• Demonstrated ability to influence cross‑functional and international stakeholders without direct authority.
• Fluent English.
• International travel is required to interact with contract manufacturers and multi‑site partners - expected maximum travel is 25%.

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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