Job description
Project Overview
Amaris is seeking a Product Industrialization Engineer to support our client in the successful introduction and industrialization of new medical device products. In this role, you will act as the key representative for product industrialization within multi-disciplinary teams, ensuring a seamless transition from product development to manufacturing. Your expertise will help drive best-in-class processes, tools, and equipment to achieve reliable, efficient, and high-quality production outcomes.
Your Role:
- Serve as the product industrialization expert within the medical device business, responsible for developing and releasing manufacturing processes for new products. This includes consideration of people, quality, processes, tools, and production performance from order to installation.
- Collaborate closely with engineering, quality, supply chain, catalog development, and manufacturing teams to ensure factory readiness for new product introductions.
- Execute processes and standards in strict adherence to safety, regulatory, and environmental requirements, as well as local laws and general business principles.
- Ensure compliance with applicable processes for product introductions, qualifications, and release.
- Oversee the transfer process and manufacturing requirements based on product specifications and test requirements provided by R&D.
- Provide proactive input to improve the manufacturability of new products.
- Identify, design, implement, and validate manufacturing processes, tools, and equipment to enable quality and efficiency, with a strong focus on process automation (not software-based, but related to industrial automation and equipment).
- Prepare and release manufacturing documentation, including work instructions, PFMEA, and process validation documents.
- Manage M-BOM and routing master data until release to delivery.
- Establish inspection and test criteria during manufacturing for client-owned components and assemblies.
Ideal Profile:
- Approximately 6 years of experience in a new product introduction or manufacturing transfer roles.
- Demonstrated hands-on experience with process automation in an industrial context, with a strong understanding of industrialization, process validation, and equipment validation.
- Hands-on experience with FMEA, 8D, SPC, RCA, and Lean Manufacturing methodologies.
- Strong understanding of manufacturing fundamentals and experience working with standard quality management systems in the medical device industry.
- Knowledge and application of Design for Manufacturing, Assembly, and Test (DFMAT) principles.
- Experience with PLM systems (preferably Windchill) and ERP systems (such as SAP).
- Bachelor’s or master’s degree in Electronics, Mechatronics (preferred), Mechanics, or Industrial Engineering.
- Willingness to travel occasionally, though not a regular requirement.
- Effective communicator in English with strong interpersonal skills.
- Team-oriented, self-driven, and committed to continuous improvement with a results- and quality-focused mindset.