Requisition ID : 60192 Title: Engineer Sr II - Electrical Manufacturing Division: Arthrex California Inc (US03) Location: ACI Santa Barbara CA (US26) Salary Range:Salary Minimum: $132,250.00 Salary Maximum: $195,500.00
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Engineering Sr II - Electrical Manufacturing will provide Manufacturing Engineering support to ACT Production Operations, Quality Engineering, Supply Chain and Product Design teams to achieve business goals. Provide Sustaining Manufacturing Engineering support and to lead projects: involving commercialization of new products; defining assembly and mechanized equipment; improvements to equipment; process performance improvements and data collection; increases in productivity and production capacity; ongoing yield improvements and reduction of costs. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Define and release manufacturing Work Instructions to guide the assembly operations.
Provide production process support on manufacturing technical issues daily.
Partner with Quality Engineering in support of Quality Management System (QMS) requirements involving medical device manufacturing and ISO-13485.
Develop procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data and perform Root Cause / Corrective Actions.
Support new product development /design transfer by leading process development and validations by participating in DFx, including Design for Manufacturing, Assembly & Test.
Drive automation to replace manual processes where economically feasible.
Support new product development & project management for mechanical and electrical designs thru all phases of the design process.
Develop and support a continuous improvement culture by utilizing lean principles to enhance quality, operational efficiency, and cost.
Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly and data collection.
Lead the design, development and test 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, Bills of Materials (BOM) and training of operators.
Work with suppliers to determine product specifications and arrange for purchase of equipment, materials, or parts and evaluates products according to specifications and quality standards.
Draft and execute validation protocols and reports including Installation, Operational and Process Qualifications (IQ, OQ, PQ) for equipment and mechanized processes.
Design, develops, and manages tooling and fixtures. Coordinates quotes and procurement of new tooling with suppliers.
Perform Gage R&R and Process Capability Statistical Analysis.
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 improvements in operational efficiencies, data collection / trending, SAP work order transaction.
Lead process improvement projects through Design of 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.
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.
Remain current with ISO/FDA/ASTM standards and internal quality assurance policies.
Support Audits as a "Subject Matter Expert."
May supervise Technicians, Engineers or be an individual contributor.
Knowledge:
Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices and regulations.
Reasoning:
Develops systemic design solutions to a variety of complex problems. May refer to established precedents and policies.
Discretion/Latitude:
Work is performed without appreciable direction. Participates in determining objectives of assignments. Plans, schedules, and arranges own activities and direct reports and team resources to accomplish objectives. Work is reviewed upon completion for adequacy in meeting objectives.
Skills:
Advanced knowledge of Materials and relevant Machine design/function. • Advanced understanding of all relevant manufacturing processes and interdependencies.
Keeps informed on emerging technologies and recommends process improvements accordingly.
Proficiency in Industry Standard (ASTM) Test Methods. • Proficiency in compliance with ISO regulations and FDA 21 CFR Part 820.
Advanced CAD/CAM software skills required. • Ability to create new complex, PLC programs (specific to automation responsibilities) or manage outside contractors. • Proficiency in developing Master Validation Strategies and Plans.
Proficiency in drafting and executing complex engineering study protocols, DOE's, analyzing data, managing, and resolving deviations and authoring reports.
Proficiency in using project management tools to plan and track projects.
Proficiency in preparing complex capital equipment proposals including cost analysis and justification (ROI).
Proficiency in new or custom equipment design.
Ability to proactively communicate ideas, results, recommendations, and status effectively in oral and written forms.
Ability to supervise technicians, contractors, and junior level engineers directly and effectively.
Ability to innovate new design solutions to modify existing equipment or design new, fully custom equipment.
Experience/Education:
B.S. in Engineering required; preferably in Mechanical, Electrical, Chemical, or Computer Engineering. ***with Focus on Electrical Engineering. ***
Minimum of 8 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.
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.
About Arthrex
Arthrex Inc., a privately held company headquartered in Naples, Florida, is a global leader in orthopedic surgical device design, research, manufacturing, and medical education committed to one mission: Helping Surgeons Treat Their Patients Better™. Arthrex has pioneered the field of arthroscopy and sports medicine and innovates more than 1,000 new products and procedures every year to advance minimally invasive orthopedics worldwide.
Our core value is Making People Better. As a leading healthcare technology innovator, we are committed to making people's lives better. The contributions we make to science and medicine have the potential to get a star athlete back in the game or improve the quality of someone's life. It is truly meaningful work.
Making People Better also signifies our corporate social responsibility and commitment to employees and communities. We make employees' lives better through job security, educational and professional growth opportunities, unique benefits and amenities, and modern facilities that promote a vibrant and dynamic atmosphere of collaboration, mutual respect, and camaraderie. We also make important economic and philanthropic contributions to the communities we serve.
As a certified Great Place to Work® and one of the country's Best Workplaces for Manufacturing and Production, Arthrex is proud of its award-winning, family business culture. With more than 6,000 employees around the world, we are growing and looking for candidates who champion our Arthrex Proud values of Innovation, Integrity, Dedication, Teamwork, and Competitive Spirit.
We invite you to explore our numerous exceptional benefits at careers.arthrex.com or visit us on LinkedIn, Facebook, Twitter
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
