Sr. Manufacturing Engineer, New Product Introduction

Avalign Technologies

  • Fort Wayne, IN
  • $85,000-110,000 per year
  • Permanent
  • Full-time
  • 9 days ago
We are seeking an experienced Senior 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.What You’ll Do:
  • 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 5 years of manufacturing experience, or equivalent combination of education and experience.
  • Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred.
  • Experience with new product introductions (NPI) and managing legacy product lifecycles.
  • Experience with Non-Conformance Material Reports (NCMR) and handling post-production activities to ensure compliance.
  • Knowledge of continuous improvement methodologies, such as Lean, Six Sigma, or similar process optimization strategies.
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
  • 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.
You should be proficient in:
  • Industrial and Manufacturing Engineering
  • ISO 13485
  • Design for Manufacturability (DFM)
  • ISO 9001 Certification Experience
  • Engineering Degree

Avalign Technologies