NPI Manufacturing Engineering Lead at Avalign Technologies

As our NPI Manufacturing Engineering Lead, you’ll be the center of gravity for new product introductions—turning customer requirements into stable, compliant, and cost-effective manufacturing processes. Your day blends collaboration, hands-on problem solving, and strategic communication that keeps our plant, suppliers, and customers aligned.

You start with a quick stand-up across customer service, manufacturing, quality, scheduling, and purchasing. Together, you align on priorities for upcoming transfers and sustaining work on legacy products. Next, you review customer specs and build out Device Master Records (DMR), ensuring processes and Design for Manufacturability (DFM) set the launch up for quality, cost, and delivery success. Midday, you lead a project call as the project manager—confirming timelines, quality checkpoints, and adherence to ISO, FDA, and customer requirements. In the afternoon, you finalize a project quote—factoring cost estimates, pricing margins, and corporate financial goals—then step onto the floor to validate processes and tackle any Non-Conformance Material Reports (NCMR) from post-production. You wrap by communicating site-specific initiatives that drive departmental, plant, and corporate operational goals.

• Coordinate cross-functionally (customer service, manufacturing, quality, scheduling, purchasing) to plan and execute new product introductions and sustain existing products.
• Serve as the primary liaison between customers and internal teams for both new and legacy projects.
• Own project management for new product launches—quality, schedule, on-time delivery, and compliance with ISO, FDA, and customer specifications.
• Create and manage DMRs, define manufacturing processes, and drive DFM to optimize cost, quality, and delivery.
• Prepare comprehensive quotes, including cost estimation and pricing margins aligned with corporate financial objectives.
• Guide product transfers through internal volume production, supplier partners, and customer locations.
• Oversee post-production activities and manage NCMR to protect compliance and product quality.
• Champion continuous improvement (Lean, Six Sigma, or similar) and support quality, operations, and purchasing to hit corporate targets.

• Bachelor’s degree in an engineering discipline and 5+ years of manufacturing experience, or an equivalent blend of education and experience.
• Background in ISO 13485, ISO 9001, or medical device manufacturing (preferred).
• Hands-on experience with NPI and lifecycle management for legacy products.
• Proficiency with NCMR and post-production compliance activities.
• Working knowledge of continuous improvement methodologies (Lean, Six Sigma, or similar).

• Self-starters who excel in a fast-paced environment.
• Quick learners eager to deepen knowledge of manufacturing processes.
• Reliable teammates who show up when it matters most.
• Collaborators with an open, positive, team-first mindset.
• Planners who can coordinate and execute across functions.
• Clear communicators—written and verbal.

• 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.

• 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.
• Growth-first culture—promotion from within and real career advancement.
• Temperature controlled environment.
• Community involvement—investing in and giving back.
• Extra resources such as travel assistance and EAP.

• Industrial and Manufacturing Engineering
• ISO 13485
• Design for Manufacturability (DFM)
• ISO 9001 Certification Experience
• Engineering Degree