Director of Manufacturing Engineering

Director of Manufacturing

Rapid Point-Of-Care IVD Platform

Benchtop Electro-Mechanical Device : Consumables

Menlo Park : Hybrid/Onsite : Estimated 25% Travel

New Product Introduction : Design Transfer : Pilot/Commercial Production

Full Time : Direct Hire : Permanent Placement

We are seeking a highly skilled and experienced Director NPI and Manufacturing Engineering to join our team, focusing on the manufacturability, serviceability, and production of Class II In Vitro Diagnostic (IVD) Sepsis workflow products.

This pivotal role will focus on developing failsafed manufacturing processes and building systems to ensure that high-quality products can be delivered on time, and at the right cost, to our customers.

The role involves early involvement in the design process, directly interfacing with our manufacturing partners, overseeing the manufacturing process to ensure optimal yield and efficiency, leading cost reduction initiatives, and facilitating the transfer of new product designs from development to production.

The successful candidate will be hands-on, methodical, and organized with great attention to detail. This person should demonstrate a deep understanding of FDA regulations, specifically for Class II IVD products, and will be proficient in ISO 13485 standards for medical devices.

Key Responsibilities:

• Serve as primary engineering contact for manufacturing partners, ensuring seamless communication and collaboration on Class II IVD product manufacturing and new product introduction (NPI).
• Champion the development of failsafe manufacturing processes and best process validation/monitoring practices at our manufacturing partners
• Monitor, analyze, and report on manufacturing yield and operational status, focusing on adherence to regulatory requirements and quality standards
• Lead projects aimed at reducing costs while maintaining compliance with the quality system
• Ensure manufacturability and serviceability of new product designs, aligning with cost, quality, and regulatory compliance objectives
• Manage the design transfer process for new products, emphasizing efficiency and regulatory compliance from development through production
• Develop process verification and validation testing plans, protocols, and reports
• Lead process FMEA/FMECA risk management activities for products
• Develop, implement, and maintain comprehensive documentation of manufacturing processes and standards in compliance with ISO 13485 and FDA regulations
• Perform root cause analysis for manufacturing issues, developing solutions that comply with regulatory standards and enhance product quality
• Remain current on regulatory guidelines and standards, incorporating best practices into manufacturing processes and product design
• Mentor team members on design for manufacturability, manufacturing efficiency, and continuous improvement practices
• Work with Quality Engineering to select and audit key suppliers
• Apply statistical methods to the testing of products and processes, and implement SPC as necessary
• Own and manage all supply chain efforts

Qualifications:

• Bachelor’s or Master’s degree in Manufacturing Engineering, Mechanical Engineering, or related field, with specific training in medical device manufacturing preferred
• Minimum of 10 years of experience in manufacturing engineering within the medical device, medtech, or biotech industry, with a focus on Class II IVD software-controlled electro-mechanical instruments and high-volume medical disposable/consumable products, preferably spanning at least 3 different companies/product lines
• Demonstrated knowledge of FDA regulations for Class II IVD products and proficiency in ISO 13485 medical devices quality management systems
• Proven track record of managing cost reduction and process optimization projects in compliance with regulatory standards
• Excellent communication skills, capable of working effectively with cross-functional teams and external manufacturing partners
• Experience with CAD software, ERP systems, and statistical analysis tools with an emphasis on applying statistical methods to testing and process control