Associate Engineer

Overview

Don’t just work somewhere, join Brasseler and be a valued team member of a world-class health care organization.

Provides a safe and welcoming environment where team members can balance their lives and develop their careers. All people and experiences are valued and respected. Different perspectives are encouraged and lead to better results. This makes us who we are and enables us to be a world-class healthcare organization. All who join us are accountable to this charge.

Quality products sold with integrity has been the hallmark of Brasseler USA from the beginning. Brasseler USA s strong reputation of providing high quality, clinician endorsed and innovative dental and medical instrumentation nationally has spanned over 40 years. We have been offering a full-range of products made in the USA since 1976. Many of our products are manufactured at our headquarters in Savannah, GA.

Explore our career opportunities below to learn more.

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 include developing creative solutions in areas of product design, developing and characterizing new robust manufacturing processes and developing a deep understanding of the latest GMP and regulatory requirements.

Must be able to execute on project deliverables to meet project and site goals.

• Provide key engineering functions on one or more teams

• 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, improvement and sustainment of manufacturing processes.

• Use engineering training in the design, development, testing, documentation and manufacturing of products with adherence to industry and 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.

• 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 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 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…