Associate Engineer

Job Overview

This role will be responsible for providing engineering skills to support product and process development in dental and medical fields. The Associate will learn and apply the latest standards and best practices in process, design, and validation of health care products.

Responsibilities

• Develop creative solutions in areas of product design
• Develop and characterize new robust manufacturing processes
• Develop a deep understanding of the latest GMP and regulatory requirements
• Execute on project deliverables to meet project and site goals

Key Responsibilities

• Provide key engineering functions on one or more teams
• Present deliverables to team leaders
• Own deliverables within larger projects
• Learn the intended use and functional requirements of dental and medical devices
• Provide manufacturing engineering support for production and assembly operations
• Develop an understanding of key performance indicators (KPIs) that influence processes
• Participate in reviews of process design for compliance with engineering principles, company standards, customer contract requirements, and related specifications
• Analyze equipment to establish operating data, conduct experimental tests and evaluate the results
• Prepare the production "package" including work instructions, travelers, drawings, labeling, etc.
• Complete equipment and process validations (IQ, OQ, PQ)
• Absorb and learn in initiatives for the development, introduction, improvement and sustainment of manufacturing processes

Design/Development

• Use engineering training in the design, development, testing, documentation and manufacturing of products with adherence to industry & GMP standards
• Contribute to design history file (DHF) creation including design review meetings, phase signoffs, and final transitions to manufacturing
• Create drawings, documentation, and specification for products as well as maintenance of documentation for existing products
• Aid and learn in continuous improvement activities focused on current product performance and costs
• Support final product verification and validation
• Update documentation for existing products
• Update work instructions, travelers, drawings, labeling, etc. based on guidance from senior staff regarding changing regulatory requirements
• Learn and support the new product introduction process from conceptualization through introduction to manufacturing
• Learn and support the new product development process
• Work to learn/master new product introduction (NPI) requirements
• Carry out testing of new products to evaluate performance and provide data for improvements/innovation
• Work to learn/master sterilization, material characterization, cleaning validations, metrology, and inspection techniques
• Work to learn/master industry standards and local regulations pertaining to the environment, health, and safety
• Develop software and controls for manufacturing applications
• Support/learn about translating physical manufacturing workflow requirements to software requirements
• Design, develop, debug, maintain, and document software components
• Support/learn about software and formatting across multiple applications and processes throughout the site
• Provide software support 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
• Support/learn User Acceptance Testing scenarios and protocols
• Complete process validations (IQ, OQ, PQ) within Operations to 21 CFR Part 11 compliance
• Support/learn development and implementation of Application Programming Interfaces (APIs)
• Support/learn integration of multiple components from various sources into software applications
• Support/learn drafting of high-level technical architecture
• Support/learn the design and assembly of devices and equipment that blend electrical and mechanical components
• Support 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 tooling to improve machine and process efficiency
• Perform maintenance on process equipment
• Generate accurate and controlled documents pertaining to process equipment

Specific Knowledge & Skills

• Bachelor’s or Masters Degree in Engineering (Mechanical, Chemical, Physics, Computer sciences)
• Ability to read and interpret documents such as operating and maintenance instructions, technical drawings, industrial standards and procedure manuals
• Ability to write routine and technical reports and correspondence
• Detail oriented, and ability to organize, document and communicate across the organization
• Proficient in MS Word, Excel, Outlook, and MS Power Point

General Skills & Competencies

• Basic understanding of industry practices
• General proficiency with tools, systems, and procedures
• Basic planning/organizational skills and techniques
• Good decision making, analysis and problem solving skills
• Good verbal and written communication skills
• Good verbal and written communication skills
• Good verbal and written communication skills
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