Development Engineer II

Nissha Medical Technologies; Colorado Springs (CO); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

401(k) with company match

Paid time off

Life and disability insurance

Professional development opportunities

Job summary

Nissha Medical Technologies is seeking a Development Engineer II to design and validate manufacturing processes for medical devices. You will create drawings, assembly instructions, and tooling concepts, working closely with Production and Engineering teams in a regulated environment.

The role requires a Bachelor's in Engineering, hands-on CAD (SolidWorks) proficiency, and experience with DOEs (MiniTab). Strong problem-solving and communication skills are essential for cross-functional

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum of 2 years of related experience in an engineering field.
• 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).
• Strong interpersonal and communication skills and ability to work in a team environment.
• Strong problem-solving skills and efficient management of time and resources.

Responsibilities

• 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.

Skills

Project planning

Teamwork

Problem solving

Time management

Communication skills

Education

Bachelor's degree in Engineering

2+ years engineering experience

Advanced degree preferred

Tools

SolidWorks

MiniTab

GD&T

Job description

JOB DESCRIPTION

Development Engineer II

About Nissha Medical TechnologiesNissha 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.At Nissha Medical Technologies, we believe our success is driven by our people. We foster an environment where curiosity is encouraged, teamwork is valued, and individuals are empowered to grow their skills and careers. If you're motivated by meaningful work, collaboration, and the opportunity to help shape the future of healthcare, you'll find a place to belong at NMT.

What You Will Do

• 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.

• medical
• dental
• vision coverage
• 401(k) with company match
• paid time off
• life and disability insurance
• professional development opportunities

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.