KEY RESPONSIBILITIES:

General

• 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
  

Process

• 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).

• Learn /master common components and equipment as well as specifications, reliability requirements, and regulatory requirements

• Assist and learn in initiatives for the development, introduction, i mprovement 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.

• Learn and support the design control process (DMR, DHF, Technical Files, etc.)

• Create drawings, documentation, and specification for products as well as maintenance of documentation for existing products.

• Assist with design models, drawing details, assembly drawings, and associated engineering documentation with 3-D parametric modeling software, MS Word, EXCEL and MS Power Point.

• Assist 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 supports the new product introduction process from conceptualization through introduction to manufacturing.

• Learn and supports the new product development process.

• Work to learn/master new product introduction (NPI) requirements

• Learn and provide support in voice of customer (VOC) surveys.

• Carr y 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.
  

Software

• Develop software and controls for manufacturing applications.

• Support /learns 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.
  

Electro/Mechanical

• Support 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.

• Learn /master the equipment and control systems utilized in the assigned manufacturing area.

• 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 SKI LLS & 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

• Basic presentation and public speaking skills

• Basic interpersonal skills

• Developing professional credibility