Manufacturing Engineer

About the role

Avalign produces innovative, high-performance, and cost-effective medical devices. We are currently seeking a Manufacturing Engineer, New Product Introduction (NPI), to join our dynamic team.

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.
• 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.

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.
• 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.
• Feel 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.
• 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.
• Tuition reimbursement.
• Grossly generous 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.