Associate Principal Engineer

• 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. Full scale leadership on production and assembly projects across the site.

• Recommend and implement process improvements for manufacturing procedures based on key performance indicators (KPIs).

• Lead reviews of process design for compliance with engineering principles, company standards, customer contract requirements, and related specifications.

• Look to develop alternative processes/materials/equipment to improve cost and efficiency but preserve the same output.

• Research future technologies to develop test methods that are accurate, time-efficient, and cost-effective.

• Review and assess the production "package" including work instructions, travelers, drawings, labeling, etc.

• Design and executenew 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. This includes introduction of Lean manufacturing techniques and a philosophy of continuous improvement.

• 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.

• Research new sterilization, material characterization, cleaning validations, metrology, and inspection techniques.

• Ensure compliance in all aspects of Environmental, Health and Safety per industry standards and local regulations.

• Own software and controls for manufacturing applications; supports development of customer-facing applications/products. Full scale leadership on applicable projects.

• Translate physical manufacturing workflow requirements and customer requirements to software requirements.

• Design, develop, debug, maintain, and document software components. Develops software to ensure formatting is transferrable across multiple applications and processes.

• 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.

• 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. Performs small-scale machine retrofits.

• 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. Designs/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.

• Bachelor's or Masters Degree in Engineering (Mechanical, Chemical, Physics, Computer sciences)

• Ability define documents such as operating and maintenance instructions, technical drawings, industrial standards and procedure manuals

• Ability to write technical reports and technical correspondence with management. Ability to review and critique junior engineers reports.

• Detail oriented, and ability to organize, document and communicate across the organization.

• 5+ years Medical or dental device manufacturing working experience

• Advanced Knowledge of regulatory requirements (FDA and others)

• High level of proficient in GMP quality standards

• Experience of executing Six Sigma and Lean Manufacturing projects and deployment and training of these concepts

• Proficient in new product development processes from concept through full production release

• Experience leading large scale projects in a manufacturing environment. The ability to manage project cost and keep withing defined budget

• Experience in research projects and product conceptualization

• Excellent understanding of industry practices

• Strong proficiency with tools, systems, and procedures

• Strong planning/organizational skills and techniques

• Strong decision making, analysis and problem-solving skills with ability to multi-task

• Excellent verbal and written communication skills

• Strong presentation and public speaking skills

• Strong interpersonal skills

• Strong conflict resolution skills and ability to deliver difficult messages

• Ability to build partnerships at all levels within the company, ability to build partnerships externally

• Good negotiating skills

• Resolve complex issues in effective ways

• Project management, consultative skills and ability to manage a budget

Typically 6 to 8 or more years of increasing responsibility in terms of any applicable professional experience.