Associate Principal Engineer

Key Responsibilities

• Lead multidisciplinary technical teams and provides key engineering functions across multiple functional groups within the site
• Present finished projects to site leadership
• Manage mid-scale projects
• Develop expertise in some areas of the dental and medical device industries
• Work with external companies/organizations on technology development while maintaining project timelines and ensuring efficient use of resources
• Take an active role in site-level decisions and initiatives
• Provide coaching/mentorship to other engineers

Process

• Ownership for production and assembly operations
• Recommend and implement process improvements for manufacturing procedures based on key performance indicators (KPIs)
• Review and assess the production "package" including work instructions, travelers, drawings, labeling, etc.
• Design and execute new process qualifications for new base technologies across multiple manufacturing platforms
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements
• Attend technical conferences and trade shows to look for new opportunities in the areas of process equipment, packaging, product treatment, metrology, materials and plan productivity
• Lead initiatives for the development, introduction, improvement and sustainment of manufacturing processes, including introduction of Lean manufacturing techniques and a philosophy of continuous improvement

Design/Development

• Use current engineering best practices in the design, development, testing, documentation and manufacturing of products with adherence to industry & GMP standards
• Manage design history file (DHF) including design review meetings, phase sign-offs, and ensures seamless transition to manufacturing
• Develop and maintain the design control process (DMR, DHF, Technical Files, etc.)
• Research new technologies to develop design concepts. Leads group ideation sessions. Creates drawings, supporting documentation, and develops product specification for new products designs
• Research/evaluate new technologies that can contribute to future product development and increase product pipeline
• Produce design models, drawing details, assembly drawings, and associated engineering documentation with 3-D parametric modeling software, MS Word, EXCEL and MS Power Point
• Ideate/lead continuous improvement initiatives focused on current product performance and costs
• Direct final product verification and validation
• Maintain all documentation for existing products
• Develop and keep current work instructions, travelers, drawings, labeling, etc. based on knowledge of changing regulatory requirements
• Manage the new product introduction process from conceptualization through introduction to manufacturing
• Provide technical leadership and strategic direction for the new product development process
• Liaise with customers and commercial teams to define product introduction (NPI) requirements. Ensures that NPI activities fulfill requirements
• Work with KOL’s to assure both design and voice of customer (VOC) requirements are properly carried out
• Develop test methods for new products and utilizes test data to iterate on product designs and author industry white papers
• Ensure compliance in all aspects of Environmental, Health and Safety per industry standards and local regulations

Software

• Own software and controls for manufacturing applications; supports development of customer-facing applications/products
• Translate physical manufacturing workflow requirements and customer requirements to software requirements
• Design, develop, debug, maintain, and document software components
• Design solutions for SLA, 3D Printing, CNC Milling, Laser Marking and Laser Trimming, X-Ray Tomography, and manufacturing systems integration with commercial software system ERP, MES and data warehousing systems
• Define User Acceptance Testing scenarios and protocols
• Design and executes validation protocols (IQ, OQ, PQ) for the site for complex change programs to 21 CFR Part 11 compliance
• Lead the design and implementation of Application Programming Interfaces (APIs)
• Integrate multiple components from various sources into software applications
• Draft high-level technical architecture with external partners
• Identify inefficiencies in current system architectures and works to rebuild them
• Research new technologies and software development practices

Electro/Mechanical

• Perform the design and assembly of devices and equipment that blend electrical and mechanical components
• Support and/or leads the development of equipment and devices at all stages, from concept creation to production tooling
• Aim to optimize safety, economy, reliability, sustainability, and quality
• Design equipment component replacements/additions to improve machine and process efficiency
• Make adjustments and improvements to existing equipment to improve efficiency
• Design and implements mid-scale automation solutions and semi-automated subassemblies
• Ensure maintenance on equipment within multiple areas is up-to-date
• Provide technical support for control systems utilized in the multiple areas
• Design/builds small-scale control systems
• Generate accurate and controlled documents pertaining to process equipment
• Research the latest technology and looks to implement in current equipment/processes