Manufacturing Eng 5

Arthrex

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Principal Manufacturing Process Engineer. This is an exciting opportunity to make your mark on a growing organization. Successful candidates will possess a minimum of a B.S. in Engineering preferably in Mechanical, Electrical, Chemical, or Computer Engineering. and 12 Yrs. experience in Design and Development or Manufacturing Engineering required. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

B.S. in Engineering required; preferably in Mechanical, Electrical, Chemical, or Computer Engineering
Minimum of 12 Yrs. experience in Design and Development or Manufacturing Engineering required.
Proven Experience leading process improvement projects.
Proven Experience leading new equipment, capital projects.
Experience leading/ supervising direct reports.
Expert knowledge of Materials and relevant Machine design/function.
Proficiency in Industry Standard (ASTM) Test Methods.
Proficiency in compliance with ISO regulations and FDA 21 CFR Part 820 with ability to assess and mitigate business and regulatory risks.

Nice To Haves

Masters Degree in Engineering or Business preferred.
Experience in medical device manufacturing or other health sciences industry preferred.
SAP, MiniTab, Solidworks experience preferred.
Lean Six Sigma Green Belt / Black Belt certification preferred

Responsibilities

Support new product development/design transfer by leading process development and validation.
Develop and support a continuous improvement culture to enhance quality, operational excellence, and cost.
Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly, packaging, data collection, and process efficiency.
Draft and execute validation protocols and reports (IQ,OQ/PQ) for manual assembly and mechanized processes.
Lead the design, development, and commercialization of new equipment including gathering user requirements, designing equipment mechanical and electrical systems, developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, BOM and Router management, and training of operations.
Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
Design, develop, and manage tooling and fixtures. Coordinate quotes and procurement of new tooling with vendors. Assess and execute validation requirements accordingly.
Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state.
Introduce and support new equipment, products, and processes utilizing industry standard project management tools and techniques.
Develop an understanding of current manufacturing processes and identify targets for improvement in data collection/trending, work order transaction processes, and operational efficiencies.
Lead process improvement projects through Designed Experiments (DOE’s), structured problem solving (Lean A3, Six Sigma DMAIC), and Statistical Analysis.
Ensure data and documentation are consistently accurate and complete.
Applies statistical methods to estimate future manufacturing requirements and potential.
Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency utilizing lean techniques when feasible.
Estimates production times, staffing requirements, and related costs to provide information for management decisions.
Develop sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data.
Remain current with ISO/FDA/ASTM standards and internal quality assurance policies. Support Audits as the process subject matter expert.
May supervise Technician, Engineering, Prototype or Programming personnel.