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Job Description
This involves being a confident advisor on quality and reliability engineering topics.
You are responsible for
Ensure that appropriate project plan and quality plans are made that include all stages of the product’s lifecycle, targets and strategy for a robust software products development.
Validates key design inputs including requirements, specifications, useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs.
Provides effective oversight during the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle.
Contribute during design and development to identify critical quality attributes (CTQ, CTS) and ensure that appropriate mitigations and design controls are applied to mitigate the risks.
Facilitate design failure mode and effect analysis to identify failure modes early in the design and development process and apply design, manufacturing and inspections to mitigate the risks.
Ensure with objective V&V evidences that design output meets the design input.
Leading quality related problem solving with the cross functional teams
Using post-market data for analytics and statistics to report on the product’s performance in the market (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when required.
Act as a single point of contact (person assigned to) for project team(s); you’re responsible to ensure the product’s design quality relatedrequirements/criteriaare complete and meet the quality standards for every project milestone.
Make substantial contribution to integrate reliability engineering activities with the medical device development activities.
Effective oversight of project deliverables and provide quality input, including safety, efficacy, regulatory. Facilitate the product defect investigations and actions during defect management review meetings.
Participate in audits and regulatory inspection as design quality SME and guide other cross-functional stakeholders on technical aspects and audit conduct.
To succeed in this role, you should have the following skills and experience
Specific skill requirements for this role include:
Bachelor’s engineering degree with 12 years / Master’s degree with 10+ years of experience; in Software Engineering , quality engineering, SW Quality- or Reliability Engineering role in the medical or aerospace industry.
Software testing experience will be an added advantage
Ability to define detailed software quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable.
Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirements.
Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality.
Ability to partner with V&V teams to assure thorough Verification, Validation and Useability testing.
Analyze development and field data for Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
Well conversant with statistical data analysis, regressionmodeling,reliability growth assessment and other quality techniques
Experience with adequate and accurate review of DHF and DMR documents.
Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971.
Experience with working in multidisciplinary teams in a high-tech R&D environment.
Effective interpersonal, written and oral communication skills expected.
Ability and willingness to work onsite
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当社の超音波診断装置の販売支援(Pre Sales活動)と納品支援(Post Sales活動)を担当します。
具体的には、担当エリアの病院を訪問し、製品の紹介・提案・説明・販売のサポート(Pre Sales活動)と製品の導入・運用のサポート(Post Sales活動)を行っていただきます。
博士 440,000円 (基本給 352,000円+30時間分の固定残業代88,000円)
修士 386,800円 (基本給 309,400円+30時間分の固定残業代77,400円)
学士 350,000円 (基本給 280,000円+30時間分の固定残業代70,000円)
準学士 325,000円 (基本給 260,000円+30時間分の固定残業代65,000円)
通勤手当:月150,000円まで支給
※通勤手当の場合新幹線・飛行機通勤は不可
年次有給休暇20日+Care leave10日+Sick leave30日
※6年目以降、年次有給休暇は25日
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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Your role:
• Responsible for guiding the development and implementation of marketing strategies and plans based on strong consumer/ customers/ people insights, enhancing our brand preference and driving consumer centric culture.
• Puts consumer and customer at the center, via thorough understanding of local/Regional needs and insights at customer and consumer level to impact Regional plans.
• Partner with RBUs, develops and reviews the activation of the (Regional) Marketing Plan and integrates marketing cadence and launch / NPI process across the region and ensures strategy and execution are synchronized.
• Lead a group of experts in CMI, CRM, Medial, Social to works closely with cross-functional teams to offer strategic inputs throughout the integrated planning cycle, ensuring that long-term planning is comprehensive and aligns with business goals.
• Evaluates the effectiveness of marketing campaigns by analyzing performance data, and use insights gained to adjust and improve strategies continually, ensuring that campaigns are optimized for better results and aligned with evolving business objectives.
• Drives media planning and effectiveness via continuous ROI improvement via MMM application, steering media briefings and delivering media plans (together with local digital managers on zone level where applicable) including Joint Business Planning with relevant partners.
• Owns external agency relationship (media, localization, creative where applicable, PR, etc.) including reviewing the roster, setting SOW and C'SAT/KPI setting and auditing results and compliance in cooperation with procurement.
• Collaborates closely with (Regional) Business leaders to develop effective channel strategies to drive market growth, and facilitates shopper excellence by orchestrating promotional planning and toolkit requirements for top customers.
• Optimizes creative content adaptation by channel based on performance, and complements with local content and activation where needed, whilst adhering to Brand and sub-Brand standards.
• Lead Healthy living lab to enhance the consumer experience and strengthen our brand.
• Is externally focused and drives a continuous benchmark in line with market, competition, consumer and customer trends.
• Plans and ensures alignment across Region for A&P planning, effectiveness and efficiency both working and non-working.
You're the right fit if:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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• Discover .
• Learn more about .

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エリアの新入社員、オペレーションのトレーニング及びGSSメンバーのスキル向上トレーニングを実施、サポートなどの業務
その他、 緊急対応
・営業事務もしくは類似する経験1年以上
過去入社者の8割以上が医療業界未経験者です。業界未経験の方でもOJTなどでしっかり研修致します。
【契約期間】契約社員(年まで有期1年毎に更新)
【就業時間】9:00-17:30休憩時間:1時間
毎週土曜日(所定休日)、日曜日(法定休日)、国民の祝日、年末年始(12月
-1月4日)
初年度有給休暇 最大20日間(年度~年度20日/6年度以降日付与)、Care Leave(年間10日間)、Sick Leave(年間最大日間)ほか
~450万円 ご経験により考慮します
【加入保険】社会保険(厚生年金保険、健康保険)・労働保険(雇用保険、労災保険)
【その他】PhiliFlexポイント:最大102,000ポイント(1ポイント=1円)
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Job Description
This involves being a confident advisor on quality and reliability engineering topics.
You are responsible for
Ensure that appropriate project plan and quality plans are made that include all stages of the product’s lifecycle, targets and strategy for a robust software products development.
Validates key design inputs including requirements, specifications, useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs.
Provides effective oversight during the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle.
Contribute during design and development to identify critical quality attributes (CTQ, CTS) and ensure that appropriate mitigations and design controls are applied to mitigate the risks.
Facilitate design failure mode and effect analysis to identify failure modes early in the design and development process and apply design, manufacturing and inspections to mitigate the risks.
Ensure with objective V&V evidences that design output meets the design input.
Leading quality related problem solving with the cross functional teams
Using post-market data for analytics and statistics to report on the product’s performance in the market (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when required.
Act as a single point of contact (person assigned to) for project team(s); you’re responsible to ensure the product’s design quality relatedrequirements/criteriaare complete and meet the quality standards for every project milestone.
Make substantial contribution to integrate reliability engineering activities with the medical device development activities.
Effective oversight of project deliverables and provide quality input, including safety, efficacy, regulatory. Facilitate the product defect investigations and actions during defect management review meetings.
Participate in audits and regulatory inspection as design quality SME and guide other cross-functional stakeholders on technical aspects and audit conduct.
To succeed in this role, you should have the following skills and experience
Specific skill requirements for this role include:
Bachelor’s engineering degree with 12 years / Master’s degree with 10+ years of experience; in Software Engineering , quality engineering, SW Quality- or Reliability Engineering role in the medical or aerospace industry.
Software testing experience will be an added advantage
Ability to define detailed software quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable.
Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirements.
Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality.
Ability to partner with V&V teams to assure thorough Verification, Validation and Useability testing.
Analyze development and field data for Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
Well conversant with statistical data analysis, regressionmodeling,reliability growth assessment and other quality techniques
Experience with adequate and accurate review of DHF and DMR documents.
Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971.
Experience with working in multidisciplinary teams in a high-tech R&D environment.
Effective interpersonal, written and oral communication skills expected.
Ability and willingness to work onsite
• Learn more about .
• Discover .
• Learn more about .
Our hybrid working model is defined in 3 ways:
These jobs might be a good fit