Manufacturing Engineer III (Heading Department)

As a Manufacturing Engineer III supporting the Heading Department, you will play a vital role in advancing precision component manufacturing through process development, equipment and tooling support, validation, and continuous improvement initiatives. This role supports forming and related manufacturing operations while delivering compliant, cost-effective, and high-quality solutions and collaborating with cross-functional teams to resolve complex technical challenges.

• ◆Provides technical leadership for continuous improvement of forming and related manufacturing operations by evaluating and implementing technologies, Lean Six Sigma methods, and process improvements that enhance quality, cost, capacity, and capability.
• ◆Supports manufacturing in meeting quality-system, documentation, product traceability capacity, product availability, and cost

within a regulated medical device environment.

• ✓Provides technical support for header and cam-machine operations, including equipment troubleshooting, upgrades, set-ups, process development, parameter optimization, and continuous improvement.
• ✓Designs and develops die and punch-form tooling and selects appropriate materials, equipment, automation, workholding, and inspection methods to support robust, repeatable, and cost-effective manufacturing processes.
• ✓Performs dimensional tolerance stack-up analyses to evaluate design requirements, process capability, tooling interactions, and potential sources of variation.
• ✓Performs assignments designed to continue the development of professional work knowledge and abilities requiring application of standard engineering techniques, procedures and criteria in carrying out a sequence of related engineering tasks, project management, statistical analysis and presentation of data and technical writing.
• ✓Leads product and manufacturing process changes, new product development, and process transfers to improve efficiency, quality, capacity, and cost; recommends design changes that improve manufacturability and assembly.
• ✓Uses PTC Creo and Windchill to support product, tooling, and process documentation. Experience with comparable CAD software, such as SolidWorks, is acceptable; training on PTC Creo and Windchill can be completed on-the-job.
• ✓Collaborates with customers, vendors, and cross-functional teams on design reviews and technical recommendations.
• ✓Plans, authors, executes, and reports on proof-of-concept experiments, design of experiments, capability studies, equipment acceptance and qualification activities, and process validations, including SAT, FAT, IQ, OQ, and PQ documentation, for assigned products, equipment, and manufacturing processes.
• ✓Authors, maintains, and reviews clear, accurate, and compliant engineering documentation, including validation plans, protocols, reports, standard operating procedures, work instructions, and operations and maintenance documentation.
• ✓Ensures assigned projects comply with applicable regulatory

and supports all company safety and quality programs and initiatives.

• ✓May perform other duties and

as assigned.

Job

and Knowledge

• ✓Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical discipline preferred.
• ✓Minimum of five years of related manufacturing engineering experience, or an equivalent combination of education and experience.
• ✓Experience with precision forming, tooling development, or high-volume manufacturing is preferred; a background in manual or automated production equipment is strongly preferred.
• ✓Experience working within a regulated medical device quality system is preferred, including familiarity with documentation control, product and material traceability, validation, change control, and good documentation practices.
• ✓Lean Six Sigma experience and demonstrated use of structured continuous improvement methods are preferred; Green Belt certification or equivalent practical experience is a plus.
• ✓Demonstrates strong written, verbal, interpersonal, and presentation skills, with the ability to clearly communicate technical information, project status, recommendations, and results to operators, engineers, leadership, customers, and cross-functional teams.
• ✓Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
• ✓Demonstrates strong organizational and project management skills and are results oriented.
• ✓Demonstrates positive interpersonal skills and professional interactions with coworkers.
• ✓Demonstrates advanced troubleshooting skills for forming processes, tooling, equipment set-up, dimensional variation, and related manufacturing issues.

Other

• ✓Understands and complies with applicable medical device