Job Description

Job Description

Job Description

About the Role:

As an Operations & Product Engineer, you will play a pivotal role in commercializing our FDA-cleared product and shaping the next generation of our platform. This is a hybrid role at the intersection of product development, manufacturing, and operations — ideal for an entrepreneurial-minded engineer who thrives in dynamic environments.

You'll work closely with our engineering, regulatory, and manufacturing partners to implement design changes, stand up manufacturing processes, support supply chain activities, and contribute to the development of future product indications.

Education:

Bachelor’s Degree in Engineering (i.e. mechanical, electrical, biomedical). An advanced degree (i.e. Master’s or Ph.D.) or certifications in relevant fields are preferred but not required.

Experience:

• 3 - 6 years of experience in the medical device industry, Healthtech or regulated product environment.
• Experience in medical device development, including design, prototyping, testing, and manufacturing
• Working knowledge of design controls, risk management (ISO 14971), and ISO 13485 QMS.
• Experience with product development and manufacturing transfer processes.
• Experience supporting FDA Class II or III medical devices.
• Exposure to electromechanical systems and/or embedded software.
• Prior work in a commercialization-stage startup.
• Familiarity with pilot production, fixture design, or process validation (IQ/OQ/PQ).

Skills and Attributes:

• Strong technical problem-solving, documentation, and cross-functional communication skills.
• Comfortable working in a hands-on, dynamic startup environment with changing priorities.
• Ability to communicate complex technical concepts to non-technical stakeholders.
• Strong organizational, problem-solving, communication skills and attention to detail.
• High proficiency in engineering design tools (Solidworks), product development software, and version control systems.
• Deep understanding of quality systems, testing protocols, and clinical validation processes.
• Ability to work independently and manage multiple priorities in a fast-paced, dynamic environment.
• Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.

Responsibilities:

Key Responsibilities:

1. Product Development & Design Support:

• Assist in the continued design and development of the company’s platform product, including collaborating with cross-functional teams to bring new product features and clinical applications from concept to reality.
• Support the preparation and documentation of design and development activities, ensuring alignment with design control requirements and industry regulations.

2. Supply Chain and Production Support:

• Support the sourcing and procurement of raw materials necessary for the production of the company’s products, ensuring timely delivery and quality compliance.
• Collaborate with suppliers to ensure materials meet specifications and quality standards.
• Serve as a liaison with the contract manufacturer to facilitate smooth production processes, including supporting builds and managing material disposition.
• Oversee equipment calibration and maintenance at contract manufacturing sites, ensuring manufacturing processes remain compliant with regulatory and quality standards.
• Help ensure efficient manufacturing transitions, from prototype to full-scale production, while maintaining high product quality and adherence to timelines.
• Assist in inventory management, tracking material usage, and optimizing inventory levels to minimize production delays.

3. Pilot Site & Post Market Field Support:

• Serve as a technical point of contact for initial pilot sites, assisting with setup, training, and troubleshooting.
• Actively support pilot program operations, collecting data on usage and user feedback to ensure product performance aligns with clinical and regulatory expectations.
• Provide technical assistance with the product as needed.
• Provide ongoing maintenance and management support for the product in the field, ensuring the product meets customer needs and any post-market issues are addressed promptly.
• Work closely with technical support teams to troubleshoot and resolve product-related issues in both clinical and non-clinical environments.
• Collect and analyze field data to support design improvements and updates to the product’s software and hardware.

inTRAvent Medical Partners is a privately held medical device company whose mission is to improve the safety and efficacy of emergent neurosurgical procedures. The Company is launching its FDA cleared novel bedside navigation system SOLOPASS 2.0, which is designed to provide healthcare providers with intraoperative imaging and navigation at the patient’s bedside.
You will be joining a small team of entrepreneurs, working with industry leading technology, in a fast-paced start up environment. We operate with urgency, integrity, and a strong sense of purpose — and we’re looking for mission-driven teammates who want to help bring meaningful technology to market.

Company Description

inTRAvent Medical Partners is a privately held medical device company whose mission is to improve the safety and efficacy of emergent neurosurgical procedures. The Company is launching its FDA cleared novel bedside navigation system SOLOPASS 2.0, which is designed to provide healthcare providers with intraoperative imaging and navigation at the patient’s bedside.\r\nYou will be joining a small team of entrepreneurs, working with industry leading technology, in a fast-paced start up environment. We operate with urgency, integrity, and a strong sense of purpose — and we’re looking for mission-driven teammates who want to help bring meaningful technology to market.\r\n\r\n\r\n** This opportunity includes equity-based compensation**

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