Senior Mechanical Engineer

Overview

A leading innovator in laser‑based technologies is seeking a Senior Mechanical Engineer to drive the development of advanced medical devices. The company is committed to creating solutions that improve lives and strives to foster a collaborative, engaging, and growth‑oriented work environment.

Responsibilities

• Lead the design and development of complex medical devices and subsystems through all phases-from requirements and design input through verification, validation, and transfer to manufacturing.
• Contribute to the development of intellectual property and propose original engineering solutions that enhance performance, reliability, functionality, and cost efficiency.
• Collaborate with marketing, customers, and cross‑functional teams to define product specifications.
• Support the technical aspects of transferring products to customers or distributors, including analyzing field feedback and recommending improvements.
• Develop and implement cost‑reduction initiatives for medical instruments.
• Ensure product designs comply with global medical device regulatory standards, including FDA requirements, ISO 13485, and CE Mark directives.
• Assist in creating and maintaining design history files and documentation required for regulatory approval and production.
• Travel occasionally (<10%) to interface with domestic partners or company facilities.

Requirements

Education

• BS in Mechanical Engineering required; MS in Mechanical Engineering preferred.
• Strong knowledge of U.S. and international regulatory frameworks governing medical devices.

Experience

• 10+ years of mechanical design engineering experience in laser, optical, or medical device industries.
• At least 5 years in a senior or lead role overseeing technical development across internal teams, external partners, and suppliers, within ISO 13485 and FDA‑regulated environments.
• Extensive background in optical system design, including alignment, stability, tolerancing, packaging, materials, coatings, and component specifications.
• Expertise in thermal management for optical systems (air cooling, fluid cooling, TECs, etc.).
• Proven ability to innovate in the development of integrated medical systems involving mechanical, optical, and electronic subsystems.
• Hands‑on experience with rapid prototyping for pre‑clinical and clinical applications.
• Strong project leadership skills, capable of managing schedule, budget, vendors, and technical deliverables.

Technical Skills

• Proficiency with 3D CAD software, preferably SOLIDWORKS and associated PDM tools.
• Strong understanding of device packaging and opto‑mechanical design principles.
• Familiarity with automation systems is a plus.
• Proficient with MS Office tools (Word, Excel, PowerPoint, Project, Visio).
• Ability to apply engineering principles to design mechanical components, systems, and mechanisms.