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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