Development 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

This is a mid-career engineering position supporting design, manufacturing development, and transfer of new products to Production. The ideal candidate knows and applies the fundamental concepts, practices and procedures of field of specialization. Under limited supervision, performs work that is varied and that may be technically challenging, and takes ownership of project deliverables and performance. Some evaluation, originality, and ingenuity is required.

• Follows 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 or regulations are met.
• Demonstrates knowledge and acts in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
• Creates specifications (drawings, specifications, manufacturing assembly instructions, work instructions, etc.) based on customer requirements
• Designs manufacturing equipment, tooling and fixtures.
• Participates in fabrication of prototypes, first articles samples, and test equipment, partnering with Production Personnel and Engineering Technicians during these activities
• Develops manufacturing processes to meet customer and NMT requirements
• Validates manufacturing processes.  Facilitates or performs process characterization and process validation on components/products according to NMT’s procedures and / or customer requirements.
• Facilitates initial tooling trials.  Troubleshoots tooling performance, process performance, design and material related issues during manufacturing start up.
• Trains Production personnel in product assembly and inspection
• Generates engineering change orders, protocols, and reports in accordance with Good Documentation Practices (GDP)
• Participates in project teams and conference calls while representing NMT to the customer.
• Develops appropriate vendor contacts, approves prototype raw materials and assists in vendor certifications.
• 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 Engineering or related field
• Minimum of 2 years of related experience in an engineering field or advanced degree
• Experience with CAD (SolidWorks strongly preferred)
• Experience designing and conducting DOEs using MiniTab
• Ability to plan activities, work independently, and complete work on schedule
• Proficient in CAD (experience in creating Engineering Drawings and applying GD&T preferred)
• Solid interpersonal and communication skills and ability to work in a team environment
• Strong problem-solving skills and efficient management of time and resources

Preferred Qualifications

• Advanced Degree preferred but not required.
• Experience working in Medical device or regulated environment
• Knowledge of medical device process validation is preferred

Professional Traits We Value

• Problem-solving ability
• Team-player

Compensation & Benefits

The expected salary range for this position is $70,000 – $90,000 annually. 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.