Manufacturing Engineer

Avalign Technologies • Fort Wayne, IN

6d • Onsite

About The Position

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.
We are seeking a Manufacturing Engineer, New Product Introduction (NPI), to join our team. In this role, you will develop, implement, and maintain engineering methods and systems to meet site-specific, customer, and regulatory requirements. You will proactively communicate initiatives that support departmental, plant, and corporate operational goals. As an engineering representative, you will provide support and guidance for new product transfers through internal volume production, suppliers, and customer locations. Additionally, you will drive new product introductions to ensure alignment with customer specifications and delivery expectations.

Requirements

• 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.

Nice To Haves

• Familiarity with MasterCam, Esprit, Partmaker, or similar CAM systems is a plus.

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 (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.

Benefits

• 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
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level