Development Engineer II

About the role

Nissha Medical Technologies (NMT) is a global 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).

Responsibilities

• Supports design, manufacturing development, and transfer of new products to Production.
• Performs work that is varied and may be technically challenging, taking ownership of project deliverables and performance.
• Evaluates, demonstrates originality, and ingenuity in performing tasks.
• Fulfills responsibilities under limited supervision, following Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies, and Standard Operating Procedures.
• 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.
• Absides by all safety and security rules set forth by the company and regulatory agencies.

Requirements

• 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 DOE's 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.

Skills

• Problem-solving ability.
• Team-player.

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. In addition, Nissha Medical Technologies offers a competitive total rewards package including medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities.