Manufacturing Process Engineer II

About Nissha Medical Technologies

Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915).

Across our global organization, our teams collaborate to design and manufacture innovative medical devices and solutions that make a real difference in patients’ lives. We partner closely with our customers to solve complex challenges, move ideas forward, and support products from concept through commercialization. Our work spans patient monitoring, surgical and interventional solutions, precision components, and emerging technologies, all grounded in a strong culture of quality, accountability, and continuous improvement.

What You Will Do

The Manufacturing Process Engineer II is an intermediate plastics processing engineer supporting product design, tooling design, manufacturing development, and manufacturing.   This position knows the fundamental concepts, practices and procedures of injection molding, mold tooling and equipment, and engineering plastics to daily operations.  They are skilled in operating injection molding equipment and performing molding process development, validation, and troubleshooting.  This role works under supervision with limited responsibility performing process engineering work that is varied and difficult in nature. Some evaluation, originality or ingenuity is required.  Typically reports to a Senior Process Engineer or Manufacturing Engineering Manager.

ESSENTIAL DUTIES AND RESPONSIBILITIES (other duties may be assigned)

• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and regulations are met.

• Demonstrate knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.

• Participate in plastic material selection, molded part design reviews, and processing equipment selection.
• Participate in mold tooling design reviews. Conduct mold flow analysis to support tooling design.
• Safely operate injection molding equipment to perform equipment set-ups, molding trials, process development, process characterization, process validation and process trouble shooting.
• Perform and document injection mold and process equipment installation qualifications (IQ).
• Perform and document molding process development, process characterization, and operational qualifications (OQ) per company procedures.
• Write protocols and reports documenting process validation activities and results.
• May lead limited scope process development, material change or continuous improvement activities or projects.
• Evaluate process results versus manufacturing requirements.
• Coordinate and schedule process activities with various required groups within organization.
• Produce production work instructions and train Production personnel on new molding processes and procedures.
• Participate in project teams and conference calls while representing company to the customer.
• Support Manufacturing and Development operations with job set-ups and troubleshooting.
• Abide by all safety and security rules set forth by the company and regulatory agencies.

• Regular attendance is required.

What You Bring

Core Qualifications

• Bachelor’s degree in Plastics Engineering
• 3 or more years’ experience in Plastics processing (i.e. molding or extrusion)
• 2 or more years’ hands-on injection molding process and tooling experience
• Experience designing and conducting engineering trials and writing reports.
• Ability to plan activities, work independently and complete work on schedule
• Trained in CAD
• Solid interpersonal and communication skills
• Ability to work in a team environment
• Strong problem-solving skills
• Efficient management of time and resources

Preferred Qualifications

• Experience working in a Medical Device manufacturing environment (preferred).
• Prior experience assisting with process documentation, IQ/OQ activities, or process troubleshooting (preferred).
• Experience in a regulated environment, such as ISO and FDA QSR (preferred).
• Advanced degree in Engineering (preferred)
   

Professional Traits We Value

• Solid interpersonal and communication skills
• Ability to work in a team environment
• Problem-solving ability

Compensation & Benefits

The expected salary range for this position is $70,000 – $90,000 annual. Actual compensation will be determined based on experience, skills, qualifications, and geographic location.

Equal Opportunity Statement

Nissha Medical Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected status under applicable law.