As the SENIOR MANUFACTURING ENGINEER (SME) you will be the customer’s point of contact to clearly understand specifications and requirements in order to develop & design an effective manufacturing plan, establish a set of procedures and routings for improving process efficiency and perform a variety of manufacturing support activities to guarantee the high-quality production of medical parts & instrumentation.
This role will focus primarily on product modifications and customizations.
Based in Kenosha, WI – this role will report directly to the Engineering Manager.
Established in 2006 in Kenosha, WI, Bradshaw Medical Inc. is a US design and manufacturer of medical equipment including orthopedic and spinal instrumentation, ratcheting drivers, compressors, distractors, and silicone over mold. Acquired in 2018 by In’Tech Medical SAS, the world’s largest contract manufacturer of surgical instruments, implants, cases & trays and silicone handles with production facilities in Europe, Asia and North America (AL & WI). In’Tech Medical SAS employs 850 people globally incl. 166 employees at Bradshaw Medical, Inc. and offers a large portfolio of standard as well as custom designs.
- Project manager for customers’ projects, providing technical support while ensuring high-level customer satisfaction
- Provide world-class customer service exceeding customer expectations.
- Perform reviews of customers’ orders and determine processing requirements to produce cost-effective conforming components and assemblies
- Develop, evaluate & improve manufacturing processes, BMI operating procedures & requirements and work instructions through analysis of application, research, design, modification, and testing of manufacturing methods and equipment
- Assist Mechanical & Quality Engineers in developing a range of machine, secondary process validations, and testing protocols (IQ, OQ, PQ)
- Support customers and BMI requirements by interacting closely with R&D, engineering team, and production; designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling and materials
- Using LEAN manufacturing tools and principles, improve the organization through effective resource allocation management, product cost reductions, reducing waste and lead time while keeping or improving quality
- Design and review blueprints and or process prints, create BOM & routings within the ERP system (Epicor)
- Participate in developing and/or creating new custom design tooling, and fixtures for all types of machine tools, as well as purchase tooling when required. Design gages as needed.
- Lead and support Corrective & Preventive Actions (CAPA) and Complaint processes to ensure timely closure, for engineering, subcontracting or manufacturing issues
- Improve quotes, and parts number database for in-house or third-party manufacturing
- Participate regularly to vendors’ and OEMs evaluations to streamline processes, resolve outstanding concerns and build up strong partnerships with engineering & purchasing teams
- Facilitate team meetings to help projects planning, assist with leading & developing the engineering team and help resolving issues
- Perform 360 reviews on new products or process assuring desired margins have been met
- Minimum of 7 years of related experience in Manufacturing Engineering in a machining production and design facility. Medical device industry experience, a plus
- Bachelor’s Degree in Engineering (Mechanical, Production or similar) preferred
- communication skills communicating with customers
- Proficient with project planning; ability to effectively manage multiple projects; proven experience in leading process improvement projects
- Strong experience with planning, developing and conducting tests to validate machine and secondary processes
- Thorough understanding of raw materials, manufacturing processes, quality control practices, and root cause analysis
- Relevant Turn-Mill, Milling, Lathes, and Swiss (up to 6 axis), Mold presses, CNC precision machining, Laser marking, Robotic and general tooling experience
- Strong LEAN manufacturing incl. Kaizen, 5S, Six-Sigma among others
- Advanced knowledge and understanding of blueprints and GD&T. Proficient in SolidWorks
- Thorough understanding of ISO 13485 / FDA 21 CFR820 (Medical Devices Quality Standards & Regulations)
- Prior experience with CAPAs and complaints, a plus
- Ability to communicate effectively in multi-discipline, cross-cultural environment, and levels of the organization
- Computer proficiency (MS Office – Word, Excel, Outlook) and ERP (Epicor)
- Maintain a sense of urgency and the ability to prioritize work. Passion to improve & challenging the status quo
- Excellent negotiation and strong written & verbal communication skills dealing with internal teams, external partners, and customers
- Ability to work under pressure, and meet deadlines, while maintaining a positive attitude
- Strive in an international & multicultural technical environment
- Able to work at a moderate noise level, with exposure to moving mechanical parts, coolants, and oils
Location: Kenosha, WI
Remuneration: Excellent Salary & Benefits package (Medical, Dental, Vision, 401K plan, Life)