Principal Manufacturing Engineer, Medical Device, San Diego

 
 
As a key member of our Device Development team, the Principal Manufacturing Engineer is responsible for strong fundamental project management expertise coupled with comprehensive technical knowledge and abilities for combination medical device development, drug filling/capping, transfer to manufacture, and strong device and process validation and verification methods. The successful Principal Manufacturing Engineer has strong engineering and manufacturing knowledge of critical medical devices to manage multiple combination device development projects in various development stages and ultimately brought to market. This Principal Manufacturing Engineer will have previous direct experience in the complete development life cycle from feasibility through commercialization within small to medium size organizations and a strong character to drive projects to completion while working within a multi-disciplinary team..
 
What you will be doing:
 

• Manage in-house and Contract Manufacturing Organization (CMO) activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements
• Develop manufacturing processes and Manufacturing Process Instructions (MPIs) and design and lot history records (DHRs, LHRs) in collaboration with Quality and CMOs
• Oversee construction of fixtures for new products, processes, and/or current product enhancements
• Ensure supply chain is aware of inventory, raw materials, and component requirements per planned build schedules
• Work with Quality personnel to help manage material issued to production
• Manage and be accountable for materials, equipment required and issued to R&D projects
• Perform time studies for manufacturing processes to identify process development/improvement initiatives
• Ensure all products are manufactured in compliance with company’s QMS, customer needs, budgetary requirements, schedule requirements, and regulatory requirements
• Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects
• Create, maintain, and manage manufacturing tasks of project schedule to ensure critical timelines and/or budgets are established and met
• Develop manufacturing specifications for products; coordinate process validation activities with Quality - IQ/OQ/PQ
• Determine tooling, equipment, and fixture needs for the timely and cost-effective manufacture of products
• Work with R&D staff to ensure smooth design transfer of products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and quality requirements
• Work with suppliers to ensure parts/services are properly documented and meet specifications
• Manage specifications for sub and final assemblies; identify tooling requirements – design/document/procure/verify tooling
• Work with Purchasing and CMOs to establish, monitor, and manage supply agreements
• Work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability
• Plan equipment and efficient workflow layouts, processes in manufacturing areas
• Manage manufacturing equipment design and development to ensure equipment is cost-effective and meets specifications
• Maintain/coordinate calibration and preventive maintenance activities in conformance with company's Quality System requirements
• Support company goals and objectives, Quality policies and procedures, Good Manufacturing Practices (GMP), and FDA/applicable regulatory regulations
• Timely informs responsible personnel of concerns involving product quality
• Manage individual projects and deliver status reports

• Bachelor's Degree in Engineering or Scientific field with min. 10 years of engineering manufacturing
• 6+ years’ experience with design transfer and manufacturing environments of Class III medical devices; combination devices (drug/device) preferred
• Extensive experience in commercializing devices from V&V phase
• Good Project Management skills
• Working knowledge of Medical Device Development Life Cycle and Manufacturing
• CMC knowledge is a plus
• Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
• Experience with statistics, Statistical Process Control and DOE techniques is desirable
• Creative problem solving and conduct failure analysis and identify critical manufacturing/process issues
• Recognized for being well organized and self-directed with strong interpersonal skills
• Ability to communicate to people at all levels of the organization and lead with influence
• Proactive, forward-thinking, and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines
• Familiarity with ISO, FDA regulations, industrial guidance documents and processes (international and CE Mark experience is a bonus)
• Energetic individual with can-do attitude and demonstrated team player
• Ability to handle multiple project and priorities with exceptional organizational and time management skills
• Ability to function efficiently, effectively, and at times independently in a fast-paced, changing environment
• Familiarity with drug fill/finish is a huge plus
• Experience in HALT/HASS testing and SPC, SIX Sigma, Lean Methods
• Understand Quality System procedures, requirements, including regulatory and training requirements for position activities
• Strong team player aligned with our Corporate Values