Japanese Bilingual Application Engineer - Medical OEM

Japanese Bilingual Application Engineer - Medical OEM

Department: Technical Project Engineering / Client Solutions Engineering

Location: Plymouth, MN

Language: Professional Fluency in English and Japanese

FLSA Status: Exempt

Working Hours: 8:30am - 5:30pm (Monday - Friday)

Industry: Medical Device Manufacturing / CDMO

OVERVIEW

A leading CDMO/OEM partner specializing in high-precision medical device components. We are seeking a Japanese Bilingual Application Engineer with a strong engineering background and exceptional communication skills.

This is a dynamic, client-facing engineering role. You will serve as the primary technical interface for U.S. medical device clients, leveraging advanced R&D and manufacturing capabilities in Japan. Operating out of Plymouth facility-which features an onsite laboratory-you will handle client requests for product testing, analysis, and reverse engineering. You will collaborate closely with engineering teams at our Japan Headquarters to bring innovative medical solutions to the U.S. market.

Essential

Duties and Responsibilities include but not limited to:

• Serve as the main point of contact for client engineers at U.S. medical device companies to understand their product requirements, technical challenges, and project goals.
• Convey client needs, specifications, and feedback accurately to the R&D and engineering teams at Japan HQ via meetings and emails.
• Utilize the onsite laboratory to execute benchmarking, testing, and investigative analysis requested by clients.
• Conduct reverse engineering on components to identify design elements and improve compatibility with company technologies.
• Travel to Japan Headquarters approximately 2-3 times a year for technical alignments, factory visits, and project reviews.
• Support rapid prototyping activities (leveraging tools like SolidWorks/Autodesk Fusion 360, 3D printing, or laser cutting where applicable) to deliver proof-of-concepts to clients.
• Ensure project alignment with medical device quality systems (ISO 13485, FDA QSR, GxP, and PMDA regulations) during client consultations and data submission review.
• Maintain a hands-on, startup mindset with the flexibility to take on ad-hoc tasks and responsibilities outside of the core job description as needed to support a growing office.

Qualifications

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Materials Science) or equivalent technical background. (Biomedical engineering degree is highly preferred).
• Professional proficiency in both English (for U.S. clients) and Japanese (for Japan HQ communication). Ability to conduct internal meetings and emails in Japanese is required (heavy formal engineering report writing is minimized).
• Experience or familiarity with engineering software (SolidWorks, AutoCAD, Matlab) and hands-on lab equipment/tools.
• Strong problem-solving skills, excellent interpersonal skills, and a high level of flexibility to thrive in a collaborative, fast-paced environment.
• Prior experience in medical device R&D, application engineering, or technical client consulting is highly preferred. Open to entry-level candidates with exceptional hands-on lab/project experience, up to mid-level engineering professionals.
• Exceptional interpersonal and relationship-building skills. High adaptability, strong problem-solving capabilities, and a proactive attitude toward taking on diverse responsibilities.

At Staffmark, we connect hardworking people with great companies, creating opportunities that make a lasting impact.

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