GENERAL DESCRIPTION:
The Senior Manufacturing & NPI Engineer will have responsibility for the design transfer of new products to the manufacturing floor. This position works closely within the Research and Development team as a Core Team member on new product development teams and is responsible for completing design transfer activities. This position requires problem-solving skills and must be able to manage complex projects to a successful and timely conclusion. This individual will work closely with others to complete projects, analyze results, and refine engineering designs.
Responsibilities will also include other upstream activities such as capital equipment, facility requirements, existing and emerging manufacturing technologies, tool design, cost estimating, and configuration control.
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This role will support the business’s goal to exceed our customers’ expectations by striving for the greatest possible quality in our products, processes, and systems.
ROLES & RESPONSIBILITIES:
· Core team member on New Product Development teams that will represent Operations and manage any and all activities related to New Product Development.
· Lead the design transfer process and ensure all activities are being completed per the project plan.
· Work with other Operations departments for both New Product Development and sustaining activities.
· Lead the root-case and corrective action response and countermeasure implementation for production issues, product defects, customer complaints, and any other technical challenge that may arise, for new products.
· Identify and implement opportunities to improve existing processes, equipment, systems, and infrastructure by leveraging and setting industry best practices.
· Train and/or provide work direction to operators/technicians.
· Collaborate with Product Development, Quality, Software Engineering, Sustaining Engineering and Operations, to define and document product development life cycle, drive improvements throughout the NPI cycle.
· Participate in the development of robust, scalable, and high-quality solutions for new product introductions (NPI) in the manufacturing environment.
· Generate and modify manufacturing process documentation.
EDUCATION & QUALIFICATIONS:
The following education and experience are required:
· Bachelor’s or master’s degree in Engineering required.
· 5+ years of manufacturing\process engineering experience required.
· Experience in bringing designs into manufacturing using the design transfer process
The following qualifications are necessary for a successful candidate:
· Ability to work within a highly collaborative team and as an individual contributor in a fast-paced, changing environment.
· Ability to leverage and/or engage others to accomplish projects.
· Strong verbal and written communications with the ability to effectively communicate at multiple levels across different shifts in the organization.
· Strong organizational and follow-up skills, as well as attention to detail.
· Ability to maintain regular and predictable attendance.
· Understand engineering principles, theories, concepts, practices, and techniques.
PREFERRED EXPERIENCES & SKILLS:
· Equipment and process validation experience in medical device or other regulated industry.
· Work with vendor/suppliers to design, procure, and fabricate equipment tooling and fixtures.
· Utilize statistical tools like Gage R&R, Cp, Cpk, and Statistical Process Controls.
· Understand manufacturing and problem-solving concepts like Value Stream mapping, 6S, and A3 to improve quality, labor efficiency, throughput, and ensuring the root cause of problem is identified and quickly resolved.
· Experience with automated or robotic equipment and systems.
WORKING CONDITIONS/PHYSICAL DEMANDS
· Must be able to read, write, and communicate in English.
· Close visual acuity to work on a computer and to determine the accuracy, neatness, and thoroughness of work.
· Will be required to work in a cleanroom environment for extended periods.
· Appropriate gowning procedures will be required for access to cleanroom (hairnet, safety glasses, cleanroom apparel/lab coats, gloves).
· Occasional environmental odors may be present.
· This is not a remote or hybrid-remote position, in-person attendance is expected.
· Occasional off-shift or weekend work may be required to support project and production timeline.