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Savannah, Georgia, United States
Onsite
Our Culture:
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.
Our Philosophy:
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.
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.
Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent a plus. May hold one or more industry certifications.
Travel typically less than 10%. Office environment. No special physical demands required.
Benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, Generous Time Off, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.
*Benefits may vary by location or status.
Henry Schein is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
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