Manufacturing Engineer: Medical Devices, Growth & Impact

Avalign Technologies, Inc.; Fort Wayne (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive compensation and benefits

Medical, dental, and vision insurance

Paid vacation and holidays

401(k) with company match

Temperature controlled environment

Community involvement programs

Job summary

Avalign Technologies, Inc. in Fort Wayne, IN is seeking a manufacturing/production-focused engineer to join our team and help troubleshoot, support operations, and validate equipment and processes to meet cost, quality, and delivery goals.

You will lead cross-functional projects, develop work instructions, and drive continuous improvement while ensuring ISO and FDA compliance. CAD experience and Lean mindset are highly valued.

Qualifications

• Bachelor’s degree in engineering with 2 years of manufacturing experience, or equivalent.
• Experience in ISO 13485, ISO 9001, or medical device manufacturing environment preferred.
• Strong background demonstrating proficiency with problem solving and root cause analysis tools.
• Ability to effectively work and communicate within a team and cross-functionally to expedite completion of critical tasks.
• Solid understanding and ability to lead Lean or TOC improvement initiatives.
• Excellent customer service skills via written and verbal communication.

Responsibilities

• Applies advanced troubleshooting and root cause analysis methods to solve problems with documented results.
• Directly supports the operations team.
• Directly supports the qualification and validation activities associated with manufacturing equipment and special processes.
• Designs and implements robust production processes and methods assuring that process capabilities are adequate to support business needs.
• Develops work instructions and necessary documentation to train associates and sustain manufacturing proficiencies.
• Collaborate with cross-functional teams to develop and coordinate new product introductions and sustain existing products.
• Act as the primary liaison between customers and internal teams for both new and legacy projects, ensuring alignment on goals and expectations.
• Develop project quotes, including cost estimation, pricing margins, and alignment with corporate financial goals.
• Lead new product projects as project manager, ensuring quality, on-time delivery, and compliance with ISO, FDA, and customer specifications.
• Create and manage Device Master Records (DMR), manufacturing processes, and design-for-manufacturing initiatives to optimize cost, quality, and delivery.
• Oversee post-production activities and manage Non‑Conformance Material Reports (NCMR) to ensure product quality and compliance.
• Drive continuous improvement initiatives and provide support to quality, operations, and purchasing teams to meet corporate goals.

Skills

Root cause analysis

Cross-functional teamwork

Project management

SolidWorks

Lean improvement

Education

Bachelor's degree in Engineering

Tools

Mastercam

Esprit

Partmaker

Job description

Avalign Technologies, Inc. in Fort Wayne, IN is seeking a manufacturing/production-focused engineer to join our team and help troubleshoot, support operations, and validate equipment and processes to meet cost, quality, and delivery goals.

You will lead cross-functional projects, develop work instructions, and drive continuous improvement while ensuring ISO and FDA compliance. CAD experience and Lean mindset are highly valued.