New Product Introduction Engineer

Premier Group; Cambridge (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

Premier Group is seeking a Staff NPI / Industrialization Engineer to bridge product development and manufacturing for next-generation drug delivery devices. You will ensure designs are manufacturable, scalable, and ready for successful commercial launch, working with Design Engineering, Manufacturing, Quality and external partners.

You will drive manufacturability reviews, support NPI and design transfer, and help shape product decisions from a manufacturing perspective in a highly regulated

Qualifications

• Experience in medical devices or regulated industries.
• Proven ability to drive manufacturability from concept through production.
• Knowledge of ISO 13485 quality systems and Design Controls.

Responsibilities

• Drive DFM and DFA throughout product development.
• Review mechanical designs to improve manufacturability and scalability.
• Identify manufacturing risks early and develop practical solutions.
• Support NPI and design transfer into manufacturing.
• Collaborate with contract manufacturers and external partners.
• Design and develop mechanical and electromechanical components and assemblies.
• Create CAD models, drawings, tolerance analyses and engineering docs.
• Design and build assembly fixtures and test equipment.
• Support Design Verification & Validation activities.
• Develop manufacturing processes, work instructions and assembly procedures.
• Work within regulated quality systems to support product commercialization.

Skills

DFM/ DFA

NPI

Manufacturing Engineering

Cross-functional collaboration

Strong communication

Education

BS or MS in Mechanical Engineering

Tools

CAD software

FEA tools

Job description

An innovative medical device company developing next-generation drug delivery technology is looking to appoint a Staff NPI / Industrialization Engineer to bridge the gap between product development and manufacturing.

This is a highly visible engineering position where you'll work closely with Design Engineering, Manufacturing, Quality and external manufacturing partners to ensure complex electromechanical products are designed for manufacturability, scalability and successful commercial launch.

If you enjoy taking products from concept through industrialisation and influencing design decisions from a manufacturing perspective, this is an outstanding opportunity to join a business at an exciting stage of growth.

The Role

As the Staff NPI / Industrialization Engineer, you'll become the key link between engineering and manufacturing, ensuring products are designed with production, assembly and scalability in mind from day one.

Responsibilities include:

• Driving Design for Manufacturability (DFM) and Design for Assembly (DFA) throughout product development
• Reviewing and influencing mechanical designs to improve manufacturability and scalability
• Identifying manufacturing risks early and developing practical solutions
• Supporting New Product Introduction (NPI) and design transfer into manufacturing
• Collaborating with contract manufacturers and external manufacturing partners
• Designing and developing mechanical and electromechanical components and assemblies
• Creating CAD models, drawings, tolerance analyses and engineering documentation
• Designing and building assembly fixtures and test equipment
• Supporting Design Verification & Validation activities
• Developing manufacturing processes, work instructions and assembly procedures
• Working within regulated quality systems to support successful product commercialization

What We're Looking For

• BS or MS degree in Mechanical Engineering or a related engineering discipline
• 10+ years of engineering experience
• At least 6 years within medical devices, biotechnology, pharmaceuticals or another regulated industry
• Experience supporting New Product Introduction (NPI), Industrialization or Manufacturing Engineering
• Knowledge of Design Controls and ISO 13485 quality systems
• Experience working closely with product development teams
• Strong communication skills with the ability to work across multiple engineering disciplines