Product Engineer, Level II

Elevaris Medical Devices • Wilmington, MA

15h

About The Position

An experienced engineering role responsible for independently executing and leading product design, development, and sustaining engineering activities within a regulated medical device environment. This position owns defined workstreams or projects, applies engineering judgment to solve technical problems, and ensures compliance with design control and regulatory requirements.

The role operates with minimal supervision and contributes to cross-functional decision-making and product lifecycle management.

Requirements

• Bachelor’s degree in engineering or equivalent, relevant experience
• 3+ years in a similar role, preferably in medical device product development
• Understanding of FDA and cGMP regulations and ISO 13485 requirements
• Technical writing skills

Nice To Haves

• Excellent organizational, verbal, written communication and problem-solving skills
• Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
• Ability to multi-task with strong attention to detail
• Proficient in MS Office Suite; SolidWorks and CAD systems
• Experience working in a start-up environment, helpful

Responsibilities

• Lead and execute assigned tasks in support of new product development activities, including prototyping, testing, verification, and validation
• Act as the engineering partner for the Commercial and Manufacturing teams in sales opportunities, by providing technical support, coordinating product development activities and bringing the opportunities to manufacturing realization.
• Prepare and maintain design control documentation in compliance with FDA regulations, cGMP requirements, and ISO 13485 standards
• Lead design transfer activities to manufacturing, ensuring product readiness, documentation completeness and successful product implementation
• Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions
• Support investigations related to product non-conformances and assist with corrective and preventive action activities (CAPA)
• Responsible for creation of engineering drawings for product, tooling utilizing SolidWorks (3D) or CAD formats
• Serve as primary engineering interface for manufacturing, quality, regulatory, supply chain and commercial teams on assigned projects
• Support or lead supplier qualification activities and contribute to specification development and evaluation.
• Provide support to QA in product non-conformances, investigations, supplier corrective actions, and corrective/preventive actions
• Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
• Other duties as assigned by management

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level