Engineer, Product Development

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