GIE - EDE Engineer 3
Onsite, Canaan, CT
- Job ID
- R-549456
- Category
- Engineering
- Location
- Canaan, コネチカット州
イノベーション、オーナーシップ、そしてヘルスケアの前進に貢献するエンジニアリングのキャリアを築く
BDのエンジニアリング・R&Dは、世界中の医療提供のあり方を形づくるテクノロジーを設計し、開発し、改良しています。あなたは科学的思考、技術的専門性、創造的な問題解決力を活かして、複雑な課題を意義あるソリューションに変えていくことになります。
機械、電気、プロセス、システム、ソフトウェア、リサーチエンジニアリングなど、どの分野を専門とされていても、BDにはイノベーションを推進するための規模、リソース、そして自由があります。明確な期待値、成果に対する責任、そして業界をリードするテクノロジーとともにキャリアを成長させる機会があります。
そして、世界最大級のメドテックカンパニーの一員として、グローバルなヘルスケアシステムに広く届けられるソリューションを形づくり、大規模に人々の生活を向上させていくことになります。
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Responsibilities:
Product Design Team: to ensure product is designed to enable a mfg. process which can produce product efficiently (target COGS) and to required quality standards.
Unit Quality Team: to ensure that equip. is designed/manufactured in compliance with regulatory requirements/industry standards.
Production Team: to ensure that equipment is designed for efficient production, and to support mfg. process. To ensure that the integrated equipment / processes are easy to operate, maintain, reliable and that equipment is operating efficiently / effectively from handover / hyper care to meet production targets.
Maintenance/Engineering Team: to ensure max. equip. uptime, and that equip. is designed for easy maintenance/repair. To ensure that equipment is maintained and serviced according to recommended schedules and procedures.
Procurement & Vendors: to ensure that components meet standards/safety and can be sourced timely/cost-effective.
Plant Quality Team: to ensure that equip. is operating within specified tolerances and products meet required quality & regulatory standards.
Program Management Team: to ensure that project meets specified requirements that equipment is delivered on time within budget.
Finance team: Support CapEx planning, forecasting, and reporting.
1. Process & Equipment Design and Development
Lead the design and development of assembly, packaging, automation, inspection, and manufacturing equipment, including mechanical, electrical, controls, vision, robotics, and software elements.
Translate product, process, quality, and capacity requirements into robust equipment and automation concepts.
Define, create, review, and maintain User Requirement Specifications (URS) aligned with manufacturing, quality, regulatory, safety, and business needs.
Develop and evaluate multiple technical solutions and concepts, considering risk, robustness, scalability, standardization, cost, and lifecycle impact.
Develop innovative concepts for mechanical systems and automation based on project requirements, industry trends, and BD standards.
Create, review, or approve 3D models, 2D drawings, layouts, and system architectures generated internally or by suppliers.
Perform or review engineering analyses and simulations (e.g., stress, strain, thermal, airflow, cycle time) to validate and optimize designs.
Lead and participate in design reviews, risk assessments, machine safety reviews, and FMEA activities to ensure compliance, safety, reliability, and performance.
Verify relationships between Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs).
Support Proof of Concept (POC) activities and Design of Experiments (DOE) to establish process windows, baselines, and capability metrics.
Optimize equipment designs to improve manufacturability, operability, ergonomics, maintainability, changeover time, reliability, and total cost of ownership.
Capture, analyze, and leverage process and equipment performance data from existing production lines to inform new designs and improvements.
Provide detailed technical and cost input for capital justification activities (e.g., CB-2), including equipment cost, engineering effort, validation scope, risk, and implementation timeline.
2. Supplier & Capital Project Leadership
Lead and coordinate external suppliers, system integrators, and equipment vendors throughout the full project lifecycle.
Support and lead vendor selection in partnership with Procurement, including RFQs, technical evaluations, supplier capability and risk assessments.
Define and manage supplier technical scope, cost, lead time, risks, deliverables, and interfaces.
Review and approve supplier designs, specifications, software architecture, electrical and mechanical schematics, and safety concepts.
Plan, witness, and approve Factory Acceptance Tests (FAT), including definition of test plans, acceptance criteria, deviation management, and re-tests.
Manage supplier corrective actions, technical changes, and continuous improvement actions.
Support contract execution, change control, and claims management in collaboration with Procurement and Legal.
Establish and maintain strong technical relationships with key equipment manufacturers and technology partners.
3. Equipment Integration, Installation, Validation & Start-Up
Drive the end-to-end integration of new equipment and processes into existing manufacturing environments.
Prepare and execute detailed equipment installation and integration plans, including site readiness, utilities, layout, logistics, EHS compliance, and resource planning.
Coordinate and support Site Acceptance Tests (SAT), commissioning, and handover readiness.
Execute and/or support equipment qualification, process verification, and process validation in alignment with Quality and Regulatory requirements.
Ensure validation strategies, protocols, and reports are completed, reviewed, and approved.
Manage and execute vertical start-up activities, ensuring equipment, process, documentation, materials, and people readiness.
Ensure training plans, operating instructions, standard work, and competence assessments are completed prior to formal handover.
Ensure minimal disruption to ongoing operations during installation, integration, or software changes.
Lead or support troubleshooting, diagnosis, and resolution of equipment, automation, process, or integration issues using structured problem-solving and root cause analysis methodologies.
4. Ramp-Up, Performance Management & Continuous Improvement
Provide sustained technical support during production ramp-up to achieve OEE, yield, throughput, scrap, reliability, and capacity targets.
Perform and support center lining activities to stabilize and optimize equipment and process performance.
Measure, analyze, and track gaps between expected and actual performance during ramp-up and early production.
Lead and support corrective actions and recovery plans to close performance gaps and ensure long-term capability.
Identify, consolidate, and implement improvement opportunities related to equipment design, integration approach, validation strategy, tools, and methodologies.
Support and lead Continuous Improvement (CI) initiatives, including Lean Manufacturing, data-driven optimization, and standardization efforts.
5. Documentation, Training & Handover
Ensure creation, completion, review, and formal handover of comprehensive equipment documentation, including URS, specifications, architecture diagrams, FAT/SAT reports, validation documentation, maintenance plans, control plans, spare parts lists, and software backups.
Support the documentation of equipment operating instructions, process parameters, standard work, troubleshooting guides, and maintenance procedures.
Support and deliver training to site personnel on new equipment, automation systems, and manufacturing processes.
Coordinate and execute formal handover to Operations, Maintenance, Engineering, and Quality teams to ensure sustainable steady-state production.
6. Compliance, Safety & Quality
Ensure all equipment, installations, and modifications comply with EHS requirements, international standards, and BD policies, including machine safety, LOTO, guarding, controls, and ergonomics.
Ensure compliance with GMP, ISO, FDA, and BD Quality System requirements throughout design, integration, validation, ramp-up, and sustained production phases.
Support internal and external audits, inspections, and regulatory interactions related to equipment and process changes.
Promote and demonstrate a strong safety, quality, and compliance culture across all project phases.
7. Leadership, Mentoring & Collaboration
Provide technical guidance, coaching, and informal mentoring to engineers and cross-functional project team members.
Lead technical discussions and decision-making across global, cross-functional teams.
Support global standardization, harmonization, and knowledge sharing across GIE and BD manufacturing sites.
Required Qualifications:
Bachelor’s Degree in Mechanical Engineering, Controls Engineering or related field, or relevant equivalent experience.
3+ years in automation / procurement and assembly and packaging experience
Experience leading projects end to end.
Willingness and ability to travel domestically and internationally up to 25%.
Preferred Qualifications:
Experience in SolidWorks or other 3d modeling software
Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts.
Experience in an FDA regulated quality environment
Knowledge and Skills:
Excellent technical skills including project management, organization, planning, and capital budgets.
Demonstrated ability to apply problem solving and data analysis methods.
Strong communication skills
Risk analysis / FMEA
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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Primary Work Location
USA CT - CanaanAdditional Locations
Work Shift
求められる人物像
BDのエンジニアリング・R&D部門で活躍する人たちには、どのような特長があるでしょうか。以下のような方は、BDのエンジニアリング・R&D部門できっと活躍できるはずです:
- 分析力のある方
- 協働的な方
- 探究心・好奇心旺盛な方
- 細部にまで注意を払える方
- 創造力のある方
- 問題解決力のある方
次のチャレンジの準備はできていますか?
ここは、大胆な発想と精密な実行を両立させたいエンジニアのための環境です。あなたは設計の意思決定に影響を与え、製品ライフサイクル全体に関わり、あなたの仕事がコンセプトから実際の世界でのインパクトへとつながる過程を見届けることができます。そのすべては、グローバルメドテックリーダーとしての規模によって支えられています
BDイノベーターの一人から、BDがどのように最先端のAIや機械学習を活用して、患者アウトカムを改善し、医療アクセスを拡大する意思決定を推進しているかをお聞きください。ここでは、あなたの仕事が世界中でリアルタイムにインパクトを生み出します。
人を中心に築かれた職場環境
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「BDは大きなグローバルカンパニーなので、周囲の人とつながり、積極的に連絡を取ることをためらわないで欲しいです。ここには学べることが本当にたくさんありますし、会社は人の育成と成長に手厚く支援をしてくれます。スポンジのようになって、できるだけ多くの知識を吸収し、自分のキャリアブループリントを最大限に活かしてほしいと思います。私は自分の仕事が本当に大好きで、BDで働けることにとても感謝しています。」
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「アイルランドのリサーチセンターでは、30カ国以上の国籍の人たちが働いていると思います。これはとても素晴らしいことで、BDについて私が最も気に入っていることの一つです。私は電気エンジニア、機械エンジニア、科学者など、多くの人々と仕事をしています。一日を通して非常に多様な視点を見聞きできることは素晴らしいことです。」
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「メドテック分野で私たちがどのようにイノベーションを続けているのか、今でも驚かされています。医療従事者にさらに多くのソリューションを届けるにはどうすべきか、技術の効率性をどのように高めるか、常に検討しています。そのすべてを、患者さんへの影響を念頭に置きながら行っています。BDで意義のある仕事を見つけられただけでなく、自分が活躍できる場所を見つけました。」
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「面接のときに、私たちの輸液ソリューションが世界中でどれほど大きな影響を与えているかを知り、感銘を受けました。鎮痛剤、がん治療、麻酔、その他の治療など、いずれであっても、自分の家族の誰かがBDの製品を使っている可能性は高いのです。ヘルスケアにこれほど大きなインパクトを与えることのできる製品の開発に携われることは、誇らしいことです。私はBDでの自分の役割が大好きです。」
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