Principal Advanced Manufacturing Engineer - medical device

InnoTech Staffing; Cuba (IL); On-site; USD 140,000 - 190,000; Full time

Job summary

InnoTECH Staffing seeks a Principal Advanced Manufacturing Engineer to lead the transition of cutting‑edge products from R&D into scalable, high‑quality production in Littleton, MA. This onsite leadership role guides design transfer, process development, and cross‑functional collaboration with R&D, Quality, and Supply Chain.

You will own process validation (IQ/OQ/PQ), leverage DOE, and mentor a team of Manufacturing Engineers while driving capital investments to scale operations.

Qualifications

• 10-15+ years of experience in manufacturing engineering, including complex electro‑mechanical and/or opto‑mechanical systems.
• Experience with disposable or single‑use medical devices is a plus.
• Strong background in process development, validation (IQ/OQ/PQ), and statistical methods/DOE.
• Proven ability to solve complex problems and make high‑level technical decisions.
• Experience influencing product design for manufacturability.
• Leadership experience, with the ability to guide and mentor engineering teams.
• Proficiency with Word, Excel, Project, and PowerPoint.
• Bachelor’s or Master’s degree in Engineering or related field (Six Sigma Black Belt a strong plus)

Responsibilities

• Lead the critical design transfer process from R&D into full-scale manufacturing.
• Develop and implement innovative manufacturing methods, tools, equipment, and processes.
• Influence product design to improve manufacturability and reliability.
• Design and launch robust manufacturing processes for new products and changes.
• Own IQ/OQ/PQ and use DOE to optimize performance.
• Establish best practices, author manufacturing procedures, and develop Bills of Materials.
• Evaluate capital equipment investments to support growth.
• Collaborate with R&D, Quality, and Supply Chain for pilot and full production.
• Provide hands‑on engineering support to resolve production challenges.
• Lead and mentor a team of Manufacturing Engineers and train technicians.
• Oversee production operations including scheduling, testing, packaging, and distribution.
• Ensure GMP, FDA regulations, and internal quality standards are met.

Skills

Leadership

Design transfer

DOE

Manufacturing engineering

Process optimization

Problem solving

Cross-functional collaboration

Education

Bachelor's or Master’s in Engineering

Tools

Word

Excel

Project

PowerPoint

Job description

Job Description

Job Description

InnoTECH Staffing is looking to hire a fulltime permanent Principal Advanced Manufacturing Engineer for a client in the Littleton, MA area.

This requires being onsite in the office.

Must be a US Citizen or Greencard Holder.

Drive Innovation from Concept to Production — Lead Manufacturing Excellence

This is a rare opportunity to take a pivotal leadership role at the intersection of R&D and manufacturing—where your work will directly shape how groundbreaking products come to life.

As a key leader in Design Transfer and Manufacturing Engineering, you will own the transition of cutting-edge products from development into scalable, high-quality production. You’ll be at the forefront of building and optimizing manufacturing capabilities, introducing innovative processes, and ensuring products are designed for reliability, efficiency, and real-world performance.

Will require occasional travel up to 10-15%.

What You’ll Do

• Lead the critical design transfer process, bringing advanced products from R&D into full-scale manufacturing
• Develop and implement innovative manufacturing methods, tools, equipment, and processes that improve productivity, quality, and cost efficiency
• Influence product design to enhance manufacturability, reliability, and serviceability from the ground up
• Design and launch robust manufacturing processes for new products, enhancements, and changes—driving toward zero-defect quality
• Own process validation activities (IQ/OQ/PQ) and leverage Design of Experiments (DOE) to optimize performance
• Establish best practices, author manufacturing procedures, and develop Bills of Materials
• Evaluate and justify capital equipment investments to support growth and scalability
• Collaborate cross-functionally with R&D, Quality, and Supply Chain to support prototype builds, pilot production, and full commercialization
• Provide hands‑on engineering support to troubleshoot and resolve complex production challenges
• Lead, mentor, and develop a team of Manufacturing Engineers while training technicians and production staff
• Oversee production operations including scheduling, build, test, packaging, sterilization, and distribution coordination
• Ensure full compliance with GMP, FDA regulations, and internal quality standards

Why This Role is Exciting

You won’t just support manufacturing—you’ll build it. This role offers the chance to define processes, influence product design, and create scalable systems that directly impact business success and patient outcomes. You’ll work on complex, high‑value electro‑mechanical or opto‑mechanical products in a fast‑moving environment where your expertise drives real change.

What You Bring

• 10-15+ years of experience in manufacturing engineering, including complex electro‑mechanical and/or opto‑mechanical systems (low‑to‑medium volume preferred)
• Experience with disposable or single‑use medical devices is a plus
• Strong background in process development, validation (IQ/OQ/PQ), and statistical methods/DOE
• Proven ability to solve complex problems and make high‑level technical decisions
• Experience influencing product design for manufacturability
• Leadership experience, with the ability to guide and mentor engineering teams
• Proficiency with tools such as Word, Excel, Project, and PowerPoint
• Bachelor’s or Master’s degree in Engineering or related field (Six Sigma Black Belt a strong plus)

Leadership Scope

• Lead and develop a small, high‑impact team of Manufacturing Engineers
• Serve as a technical and strategic leader across engineering and operations

If you're looking for a role where you can take ownership, drive innovation, and make a measurable impact from concept through production—this is it.

The client is a vertically integrated optics company primarily focused on leveraging its proprietary micro‑optics, 3D imaging and digital imaging technologies to the healthcare and defense/aerospace industries by providing services ranging from new product concept through mass manufacture.