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Skydio
San Mateo, CA, United States
Skydio is the leading US drone company and the world leader in autonomous flight, the key technology for the future of drones and aerial transportation. The Skydio team combines deep expertise in artificial intelligence, best-in-class hardware and software product development, and operational excellence to empower a broader, more diverse audience o
Job Source: SkydioKMR Search Group
Palo Alto, CA, United States
Job Description Job Purpose : Accountable for facility design and renovation, construction project management and the harmonization of facility engineering systems and maintenance and Health, Safety and Environmental procedures and practice to assure proper office accommodation, cleanroom manufacturing space, warehousing and a safe work environmen
Job Source: KMR Search GroupCepheid
san jose, ca
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development
Job Source: CepheidCepheid
santa clara, ca
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development
Job Source: CepheidCepheid
Sunnyvale, CA, United States
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development
Job Source: CepheidCepheid
sunnyvale, ca
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development
Job Source: CepheidCepheid
campbell, ca
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development
Job Source: CepheidCepheid
palo alto, ca
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development
Job Source: CepheidMenlo Park, CA, United States
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
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Email Alert for Director of Manufacturing Engineering jobs in Menlo Park, CA, United States
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