The Patient Specific Solutions team provides customized devices to those with complex clinical needs, such as oncology, where no other device exists on the market to treat their condition. As a Product Development Engineer, you will transform clinical requirements into patient-specific solutions, partnering with surgeons, operating room staff, clinical teams, and cross-functional stakeholders to deliver designs that support individual patient treatments. You will manage multiple cases, create technical documentation for manufacturing and inspection, and contribute to delivering high-quality solutions within established timelines and regulatory requirements. This role combines engineering design, clinical collaboration, and technical problem-solving in a fast-paced environment where each case presents unique challenges.

This is a hybrid role based in Mahwah, NJ, requiring you to be on-site 3 days per week, so candidates must live within a commutable distance.

What you will do:

• Design and develop patient-specific orthopedic implants and associated instruments using clinical imaging data, including X-rays, CT scans, and MRI scans.
• Create and release technical drawings and 3D CAD models that enable manufacturing and inspection activities.
• Apply geometric dimensioning and tolerancing (GD&T), finishing specifications, and tolerance stack calculations to support manufacturable designs.
• Perform engineering calculations and design verification activities to support product design requirements and design validity.
• Develop surgical planning guides, operating instructions, and supporting documentation for patient-specific devices and instrumentation.
• Collaborate with surgeons, operating room staff, clinical teams, distributors, and sales representatives to gather design inputs and provide technical support throughout the case lifecycle.
• Manage multiple patient cases simultaneously while meeting established project timelines and quality requirements.
• Create and maintain design documentation in accordance with quality system procedures, design controls, risk management processes, and regulatory requirements; attend surgical or clinical cases when required.

What You Will Need
Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or another Engineering discipline.
• Minimum 0 years of professional engineering experience.

Preferred Qualifications

• Minimum 1 year of experience in product development, mechanical design, medical device engineering, or a related field
• Completion of an engineering internship, co-op program, or capstone project involving mechanical design, product development, medical devices, manufacturing, or related engineering work.
• Experience using CAD tools such as Creo, 3Matic, Mimics, or similar engineering software.
• Knowledge of CT segmentation, engineering analysis methods, materials, and manufacturing processes.

US20: $83,400 - $133,100 USD Annual