Phillips-Medisize is seeking a Product Design Engineer to design and develop innovative drug delivery devices in accordance with the Phillips-Medisize Design Development Process (DDP), Design Controls, ISO 13485, and ISO 14971 requirements. The role involves end-to-end product development activities including concept development, detailed design, risk management, engineering verification, and manufacturing support for mechanical and electro-mechanical medical devices.

Key Responsibilities

• Design and develop drug delivery devices using NX, SolidWorks, or Creo.
• Generate complex 3D models, assemblies, and engineering drawings compliant with ASME Y14.5 and ISO 1101 standards.
• Perform engineering analysis including tolerance stack-up analysis, theoretical calculations, and simulations.
• Conduct design risk assessments using dFMEA, pFMEA, and ISO 14971 methodologies.
• Develop and implement risk mitigation strategies and verification test plans.
• Design assembly fixtures, test fixtures, and manufacturing support equipment.
• Integrate electronic components and subsystems into product designs.
• Select and develop mechanical components including plastic, metal, elastomeric, spring, and sheet metal components.
• Support material selection for drug-contacting and non-drug-contacting components.
• Create and maintain Design History File (DHF) documentation, Engineering Change Orders (ECOs), and Design Approval documentation.
• Perform component verification testing and support engineering investigations.
• Collaborate with manufacturing, quality, regulatory, suppliers, and global engineering teams to ensure successful product development and transfer.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Mechanical Design, or Mechatronics.
• 3-5 years of product design and development experience.
• Minimum 3 years of experience designing medical devices, healthcare products, or drug delivery devices such as auto-injectors, pen injectors, wearable pumps, or related products.
• Strong expertise in plastic injection molding and product development.
• Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA).
• Hands-on experience with plastic assembly technologies including snap fits, ultrasonic welding, press fits, sealing, and bonding.

Required Technical Skills

• Proficiency in NX, SolidWorks, or Creo CAD platforms.
• Strong knowledge of GD&T (ASME Y14.5 / ISO 1101).
• Understanding of ISO 13485 and ISO 14971 requirements.
• Experience with tolerance analysis and engineering calculations.
• Knowledge of plastic materials, material selection, and molding limitations.
• Experience with prototype development methods such as SLA, machining, molding, and 3D printing.
• Familiarity with engineering change management and design documentation practices.

Preferred Skills

• Experience with electro-mechanical medical device development.
• Knowledge of Design Controls and regulated product development environments.
• Strong technical communication and stakeholder management skills.
• Ability to manage multiple projects and priorities simultaneously.
• Self-driven, analytical, and customer-focused approach.