Manufacturing Engineer

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 produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.

Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.

What You’ll Do:

• 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 (customer service, manufacturing, quality, scheduling, purchasing) 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.

What You’ll Need:

• Bachelor’s degree in an engineering discipline with 2 years of manufacturing experience, or equivalent combination of education and experience.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred.
• Strong background demonstrating proficiency with problem solving and root cause analysis tools.
• Must have the ability to effectively work and communicate within a team and cross functionally to expedite completion of critical project tasks.
• Solid understanding and ability to lead Lean or TOC improvement initiatives.
• Excellent customer service skills via written and verbal communication required.
• Modeling/drafting experience with Solidworks or similar CAD systems.
• Working knowledge of drafting standards and geometric dimensioning and tolerancing.
• Familiarity with MasterCam, Esprit, Partmaker, or similar CAM systems is a plus.

What You Won’t Do:

• Feel stuck – we offer great opportunities to advance and learn
• Get bored – we make a high variety of products, so no day is the same
• Feel like a number – we’re a close-knit bunch and always have each other’s backs

Who You Are:

• A self-starter who thrives in a fast-paced environment
• A quick learner who is always ready to gain depth of knowledge in manufacturing processes
• A reliable individual who knows the importance of showing up when it counts
• Someone who accept assignments with an open, cooperative, positive and team-oriented approach
• Someone who is able to plan and execute plans across teams
• An effective communicator, both written and verbal

What You’ll Enjoy:

• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer funded Basic Life and AD&D insurance
• Employer funded STD and LTD insurance
• Great 401(k) with company match
• Working for a thriving, performance-based company that values promoting from within and career advancement
• Temperature controlled environment
• Community involvement investing and giving back to the community
• Additional free resources such as travel assistance, EAP, etc.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S.