Product Engineer, Level I

Elevaris Medical Devices • Wilmington, MA

1d

About The Position

An early-career engineering position responsible for supporting product design, development, and sustaining engineering activities within a regulated medical device environment. The role performs assigned technical tasks under the direction of senior engineering staff and contributes to design control, documentation, and cross-functional product support activities.
This position has limited independent decision-making authority and is expected to develop technical proficiency and regulatory knowledge under supervision.

Requirements

• Bachelor’s degree in engineering (Mechanical, Biomedical, Manufacturing, or related discipline), or equivalent, relevant experience
• 0–3 years of relevant engineering experience (internship or co-op experience acceptable)
• Working knowledge of fundamental engineering principles
• Basic understanding of FDA, cGMP, and ISO 13485 regulatory requirements
• Proficiency in Microsoft Office Suite
• Experience with SolidWorks or similar CAD software is required
• Effective written and verbal communication skills

Nice To Haves

• Exposure to medical device product development
• Experience supporting verification and validation testing
• Familiarity with structured problem-solving methodologies
• Experience in a regulated manufacturing environment

Responsibilities

• Execute assigned tasks in support of new product development activities, including prototyping, testing, verification, and validation
• Act as the engineering partner for the Commercial team in sales opportunities and manufacturing team 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
• Support design transfer activities to manufacturing, ensuring documentation and specifications are complete and accurate
• Assist in sustaining engineering activities, including implementation of design changes, documentation updates, supplier changes, remediation activities, and product extensions
• Create and revise engineering drawings, 3D models, and specifications using SolidWorks or other approved CAD systems
• Support investigations related to product non-conformances and assist with corrective and preventive action activities (CAPA)
• Provide technical support to Manufacturing, Quality, Regulatory, and Supply Chain functions as assigned
• Assist in supplier qualification activities and specification development
• Works under direct supervision of senior engineers or engineering management
• Follows established engineering procedures and quality system requirements
• Escalates technical issues and decision points appropriately
• Limited authority to approve documentation as defined by company procedures
• Maintain accurate engineering records in accordance with document control requirements
• 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: Entry Level