Senior Device Engineer

About the Role

Lupin Inc. has established a new Research and Development Center in Coral Springs, FL, focused on the development of generic and branded pharmaceutical products. This role will provide device and primary packaging expertise within a cross-functional drug product development organization.

Responsibilities

• Lead and coordinate the development and manufacturing of clinical and commercial device components and assembled devices in compliance with corporate, government, and industry standards.
• Provide recommendations on strategies for device material selection, design concepts, cost-reduction, high-volume manufacturing, and process streamlining.
• Collaborate with internal and external development partners, monitoring progress and supporting technical development, testing, and verification.
• Define product requirements for medical devices and drug/device combination products.
• Design, plan, perform, interpret, and report studies related to device development, reliability testing, quality, and documentation.
• Develop efficient and robust devices and processes for manufacturing and analysis, including risk management activities.
• Lead and monitor documentation work for high-quality Design History Files (DHF) and human factors studies.
• Support Regulatory Affairs in preparing pre-registration documents and responding to Health Authority questions.
• Lead or support interactions with Health Authorities and medical device industry governing bodies.
• Coach team members, participate in project sub-teams, and contribute to overall strategies and goals.

Requirements

• Relevant degree in Engineering (minimum requirement).
• At least 5 years of experience in a similar role, with continuing education (EU) or a BSc or equivalent.
• Advanced degree in a scientific or relevant discipline (MSc or equivalent) and at least 5 years of experience in the medical device industry (highly desirable).
• Pharmaceutical development experience, particularly with dry powder inhalers (DPI), metered dose inhalers (MDI), nasal sprays, and nebulizers.
• Expertise in medical devices, including product design, injection molding of plastic components, testing, and verification tools.
• Proficiency in force measurement, metrology, and qualification of special tools/equipment.
• Experience with development and documentation of medical devices and drug/device combination products, including Design Control and Design History Files (DHF).
• Knowledge of regulatory, QA, cGMP, and industry best practices (ISO, ASTM, ICH standards).
• Experience conducting FMEA, FMECA, and Human Factors Analysis.
• Proficiency with medical device industry software tools (e.g., SolidWorks, CAD) and general computer tools.
• Ability to work in and/or lead teams within a matrix organization.
• Strong leadership, coaching, communication, presentation, and technical writing skills.

Skills

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility