Hardware Engineer – Mechanical /ハードウェアエンジニア – 機械（医療機器）

Job Requirements

［客先］ Customer Name

日系大手医療機器メーカー

Major Japanese Medical Device Manufacturer

［募集背景］ Summary

機械系ハードウェアエンジニアとして、医療機器および医療用消耗品向けの機械部品・構造アセンブリの設計、開発、評価・検証をご担当いただきます。臨床ニーズや顧客要求を理解し、信頼性・安全性・製造性を考慮した製品設計へと落とし込みながら、革新的な医療機器の開発を推進していただきます。また、品質保証、生産技術、製造、プロジェクトマネジメントなどの部門横断的なチームと密接に連携し、医療機器に関する品質基準および各種規制要件に準拠した製品開発を担っていただきます。

As a Hardware Engineer specializing in Mechanical Engineering, you will be responsible for the design, development, and verification of mechanical components and structural assemblies for medical devices and medical consumables. You will translate clinical and customer requirements into innovative, reliable, and manufacturable product designs while collaborating closely with cross-functional teams to ensure compliance with quality standards and medical device regulations.

［業務内容］ Responsibilities

• SolidWorks、Creoを使用した3D CAD設計
• 樹脂成形品や機械部品の設計
• 試作品の評価・検証
• 各種実験および技術レポート作成
• 設計仕様書や技術文書の作成
• 品質・製造・開発チームとの連携
• Design and develop mechanical components for medical devices
• Create 3D CAD models and drawings using SolidWorks or Creo
• Design plastic molded and mechanical parts
• Perform prototype testing and design verification
• Conduct experiments and prepare technical reports
• Create and maintain engineering documentation
• Collaborate with Quality, Manufacturing, and Development teams
  
  

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.

Work Experience

■必須要件■ Must Have

• 医療機器、精密機器、または規制産業における機械設計・製品開発経験（3年以上）
• SolidWorks、Creoなどの3D CADを用いた設計経験
• プラスチック射出成形部品、板金部品、または機械加工部品の設計経験
• 設計検証、試験評価、技術文書作成の実務経験
• 医療機器、電気機械式機器の分野での実務経験
• Minimum 3 years of experience in mechanical design and product development within the medical device or other regulated industries
• Hands-on experience in 3D CAD design using SolidWorks, Creo, or similar CAD tools
• Experience designing injection-molded plastic parts, sheet metal components, and/or machined parts
• Practical experience in design verification, product testing, evaluation, and technical documentation
• Experience working in medical devices, Electromechanical devices
  
  

■尚可要件■ Good to Have

• Ansysなどを用いた構造解析・熱解析の経験
• ISO 13485、ISO 14971、IEC 60601-1などの医療機器規格に関する知識
• dFMEA、RCA、8Dなどの品質改善手法の経験
• Experience with engineering analysis, including structural and thermal simulations using Ansys
• Knowledge of medical device regulations and standards such as ISO 13485, ISO 14971, and IEC 60601-1
• Experience with quality and risk management methodologies, including dFMEA, Root Cause Analysis (RCA), and 8D problem-solving
  
  

■語学力■ Language Skill

• 日本語‐ネイティブレベル/ JLPT N1 レベル
• 英語‐ビジネスレベル
• Japanese – Native Level or JLPT N1 Level
• English – Business Level
  
  

[待遇・福利厚生]

◆昇給年1回 ※契約社員は更新のタイミングで見直しあり

◆通勤手当（上限2万円/月）

◆給与詳細：完全年俸制（1/12を毎月支給）

◆残業手当

◆各種社会保険完備

・ 厚生年金

・ 健康保険（TJK : 東京都情報サービス産業健康保険組合）

・ 雇用保険

・ 労働者災害補償保険

◆健康診断（被扶養者健康診断、人間ドック、婦人科健診など）

◆65歳定年制 ※役職定年なし

◆社内研修制度（オンライン）

◆試用期間3ヶ月、業務・待遇変更なし

◆受動喫煙防止対策：あり（屋内禁煙）

[Welfare]

◆ Salary increment once a year

◆ Commuting allowance (up to 20,000/month)

◆ Salary details: Full annual salary system (1/12 paid monthly)

◆ Overtime allowance

◆ Equipped with various social insurance

・ Welfare pension

・ Health insurance (Tokyo Information Service Industry Health Insurance Association)

・ Employment insurance

・ Worker's Accident Compensation Insurance

◆ Health checkup (health checkup for dependents, medical checkup, gynecological checkup, etc.)

◆ Retirement age is 65 years old *No retirement age for positions

◆ Referral recruitment system (with benefits)

◆ In-house training system (online)

◆ Trial period: 3 months, no change in duties or benefits

◆ Measures to prevent passive smoking: Yes (no smoking indoors)

[休日休暇]

◆年間休日120日以上

◆完全週休2日制（土・日）

◆祝日

◆年末年始休暇

◆有給休暇

◆産前産後休暇

◆育児休暇

◆介護休暇

◆忌引休暇

※常駐先の業務にともなって休日・休暇は変動の可能性があります。すべて大手メーカーのため、年次休暇などは充実している場合がほとんどです。

[Vacations]

◆ Total holidays: over 120 days off per year

◆ 2-day weekend system (Saturday and Sunday)

◆ National Holidays

◆ New Year holidays

◆ Paid vacation

◆ Prenatal and post-natal leave

◆ Childcare leave

◆ Nursing care leave

◆ Bereavement leave

• Holidays and vacation days may change depending on the work place you are stationed. Since they are all major manufacturers, most have generous annual vacations