R&D & NPI Projects Leader
About the Role
Novoxel is seeking a highly motivated and experienced R&D & NPI Projects Leader to drive
product innovation from concept through commercialization and mass production. In this key
leadership role, you will manage the development of new products, lead production
improvement initiatives, and execute engineering projects related to product design and
manufacturing.
Working closely with cross-functional teams, including Software Engineering, Manufacturing,
Quality, Regulatory Affairs, Clinical, and Service, you will ensure that projects meet Novoxel's
high standards for quality, performance, cost, regulatory compliance, and on-time delivery. As
the engineering lead for New Product Introduction (NPI), you will own the Design History File
(DHF), Design Change Controls, and the overall verification, validation, and
transfer-to-production strategy.
* Key Responsibilities
Project Leadership & Strategy
- Lead engineering projects throughout the entire product lifecycle, from concept and
planning through design, verification and validation (V&V), regulatory submission
support, and transfer to manufacturing.
- Develop project plans, define priorities, and manage schedules, risks, budgets, and
external engineering resources.
- Coordinate multidisciplinary teams to ensure timely execution and successful project delivery.
- Collaborate closely with Manufacturing, Quality, Regulatory Affairs, Clinical, Service, and
Supply Chain teams to ensure product designs are manufacturable, serviceable,
compliant, and aligned with business objectives.
* Product Development & New Product Introduction (NPI)
- Lead the mechanical design and development of new medical devices and significant
product enhancements in accordance with design control requirements.
- Manage engineering activities throughout the NPI process, including requirements definition, design reviews, prototyping, verification, validation, and production transfer.
- Lead Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs)
throughout the product lifecycle.
- Drive continuous improvements in manufacturing processes, production stability,
product reliability, and cost optimization.
- Support manufacturing scale-up and ensure robust production readiness.
Quality, Compliance & Problem Solving
- Own and maintain Design Files, ensuring compliance with applicable medical device
regulations and quality system requirements.
- Develop and maintain the Validation Master Plan (VMP), equipment qualification, process validation, documentation, and related validation activities.
- Lead structured root cause investigations using appropriate problem-solving methodologies.
- Ensure engineering documentation remains complete, accurate, and audit ready.
- Develop tools and methods to address day to day engineering challenges using modern
AI tools and techniques.
Requirements: Qualifications & Experience
Technical Qualifications
Bachelor's degree (B.Sc.) in Mechanical Engineering.
Minimum of 5 years of experience in the medical device industry.
At least 4 years of hands-on mechanical design experience involving precision
machining, sheet metal, plastic injection molding, mechanisms, and electromechanical assemblies.
Experience designing manufacturing equipment, automation systems, production
fixtures, inspection jigs, and assembly tools.
Strong proficiency in SolidWorks, including complex assemblies and drawing generation.
Familiarity with Design Controls, Design History Files (DHF), risk management, verification and validation (V&V), and Engineering Change
Control processes.
Professional Skills
Strong project management and organizational skills, with the ability to manage multiple priorities simultaneously.
Excellent inte
This position is open to all candidates.