Product Design Engineer

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.

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.

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.

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.

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.

Who We Are

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Email

Facebook

X

LinkedIn