Senior Mechanical Engineer – Automation

An innovative and growing medical device manufacturer is seeking a Senior Mechanical Engineer – Medical Device Automation to lead the design, development, and implementation of advanced manufacturing automation solutions. This is an excellent opportunity for an experienced engineer who thrives on building automation systems from concept through production while helping scale manufacturing operations.

In this highly visible role, you'll lead automation initiatives that improve throughput, quality, and efficiency while ensuring compliance with medical device regulations and industry standards.

• Lead the design and implementation of custom automated assembly and test equipment.
• Design mechanical systems, fixtures, and tooling using Solid Works.
• Manage automation projects from concept through production, working closely with external automation integrators.
• Develop User Requirement Specifications (URS) and oversee Factory and Site Acceptance Testing (FAT/SAT).
• Author and execute validation protocols (IQ/OQ/PQ) to ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
• Provide technical support and continuous improvement for existing automated manufacturing equipment.
• Collaborate with R&D, Manufacturing, Operations, and Quality teams to ensure successful product launches and scalable manufacturing processes.
• Drive Lean Manufacturing and Six Sigma initiatives to improve productivity and operational performance.

• Bachelor's degree in Mechanical Engineering, Mechatronics, or a related engineering discipline.
• 5–8+ years of mechanical engineering experience.
• At least 3 years of experience developing automation within a medical device manufacturing environment.
• Advanced Solid Works experience (CSWP certification preferred).
• Experience with robotics (Fanuc, Epson, or similar), machine vision systems (Cognex, Keyence), automated assembly equipment, and high-speed pick-and-place systems.
• Demonstrated success leading automation projects valued at $500K+ from concept through implementation.
• Strong understanding of Design for Manufacturability (DFM), validation, and regulated manufacturing environments.
• Experience with Lean Manufacturing, Six Sigma, and continuous improvement methodologies.

• A hands-on engineering leader who enjoys solving complex manufacturing challenges.
• Strong project management and vendor management experience.
• Excellent troubleshooting and analytical problem-solving skills.
• Ability to balance strategic automation initiatives with day-to-day manufacturing support.
• Outstanding communication and cross-functional collaboration skills.
• A passion for innovation, precision, and continuous improvement in a highly regulated manufacturing environment.

• Play a key role in transforming and scaling advanced medical device manufacturing.
• Lead impactful automation projects from concept through implementation.
• Work with cutting-edge robotics, automation, and vision technologies.
• Join a collaborative engineering team where your ideas and technical expertise will directly influence manufacturing success.
• Competitive compensation and benefits package with long-term career growth opportunities.