Company Overview:
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 overmold. Acquired in 2018 by In’Tech Medical SAS, the world 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.
In this context, we have been retained to search for a SENIOR MANUFACTURING ENGINEER (SME) who will be the customer point of contact to clearly understand specifications and requirements in order to develop & design 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 products’ modifications and customizations. Based in Kenosha, WI – this role will report directly to the Engineering Manager.
Job Description:
- Project manager for customers’ projects, provide 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, 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, parts number database for in-house or third-party manufacturing
- Participate regularly to vendors’ and OEMs evaluation 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 review on new product or process assuring desired margins have been met
Qualifications:
- 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 organization
- Computer proficiency (MS Office – Word, Excel, Outlook) and ERP (Epicor)
- Maintain sense of urgency and ability to prioritize work. Passion to improve & challenging status quo
- Excellent negotiation and strong written & verbal communication skills dealing with internal teams, external partners, and customers
- Ability to work under pressure, meet deadlines, while maintaining a positive attitude
- Strive in an international & multicultural technical environment
- Able to work in a moderate noise level, with exposure to moving mechanical parts, coolants and oils
Location: Kenosha, WI
Employment: Full-Time
Remuneration: Excellent Salary & Benefits package (Medical, Dental, Vision, 401K plan, Life)
