Principal Packaging Engineer

Purpose

The Principal Packaging Engineer provides technical leadership and strategic oversight for packaging systems supporting medical devices from concept through commercialization and post ‑ market sustaining activities. This role leads high ‑ impact initiatives across new product development, regulatory programs (e.g., EU MDR), sustainability, and value improvement, ensuring packaging designs meet functional, regulatory, sterility, and supply ‑ chain requirements. The Principal Packaging Engineer serves as a subject ‑ matter expert in medical device packaging and a mentor to other engineers.

Key Responsibilities

• Provide technical leadership and decision ‑ making authority for packaging systems across multiple product platforms.
• Serve as subject ‑ matter expert for medical device packaging, including sterile barrier systems, labeling, and distribution configurations, and maintain awareness of industry trends, standards updates, and emerging technologies relevant to medical device packaging.
• Lead packaging development activities from concept through commercialization in compliance with medical device design controls. Define project plans, timelines, scope, and deliverables for packaging ‑ related activities.
• Define packaging design inputs, design outputs, verification, and validation requirements.
• Lead and support package integrity, transit, shelf ‑ life, and test ‑ method validation activities.
• Ensure compliance with applicable regulations and standards including ISO 11607, ASTMs, ISTAs, cGMPs, FDA, CE Mark, and EU MDR.
• Provide technical oversight for packaging changes related to sustaining engineering, quality improvement, cost reduction, and regulatory compliance, while assessing and mitigating risks related to sterilization, material compatibility, transportation, shelf life, and usability.
• Develop and approve packaging specifications, protocols, reports, and technical documentation.
• Partner with manufacturing sites and suppliers to ensure robust, scalable, and cost ‑ effective packaging solutions.
• Support packaging equipment selection, process capability studies, and process validation activities.
• Oversee prototype builds and testing with internal teams and external vendors.
• Manage multiple packaging initiatives across cross ‑ functional teams including R&D, Quality, Regulatory, Operations, and Supply Chain.
• Communicate technical status, risks, and mitigation strategies to stakeholders and leadership.
• Manage either directly or indirectly packaging engineers assisting the projects and providing technical expertise and mentorship.
  
  

Qualification

• Advanced knowledge of medical device packaging systems, materials, and test methodologies.
• Strong expertise in ISO 11607, ISTA, ASTM, and relevant international packaging standards.
• Proven ability to lead complex technical projects and cross ‑ functional teams.
• High engineering acumen, including design of experiments (DOE), risk analysis, and data ‑ driven decision making.
• Experience with sterilization modalities and their impact on packaging materials and systems.
• Excellent written and verbal communication skills.
• Ability to independently develop, execute, and document technical assessments, protocols, and reports.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Proficiency with Microsoft Office and project management tools (e.g., Microsoft Project, Smartsheets).
• Ability to manage multiple priorities simultaneously.
• CAD (SolidWorks) knowledge is a plus
  
  

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum of 10 years of relevant experience in medical device packaging and/or product development within a regulated environment, or equivalent combination of education and experience.
• Demonstrated experience leading packaging development activities across the full product lifecycle from concept through commercialization.
• Experience operating in a regulated design controls environment required.
  
  

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