GIE - EDE Staff Engineer
Onsite, Sandy, UT
- Job ID
- R-549458
- Category
- Engineering
- Location
- Sandy, ユタ州
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 / R&D Teams: Ensure products are designed to enable efficient, scalable, and compliant manufacturing processes meeting cost, quality, and regulatory objectives.
Manufacturing & Operations Teams: Ensure integrated equipment and processes are operable, reliable, maintainable, and capable of meeting production targets from handover through steady-state operations.
Quality & Regulatory Teams: Ensure compliance with validation strategies, GMP, ISO, FDA, and internal quality system requirements.
Maintenance & Engineering Teams: Ensure long-term equipment reliability, center lining strategies, spare parts management, and maintenance readiness.
Program & Project Management: Ensure alignment on scope, cost, schedule, risk, and delivery milestones.
Procurement, Suppliers, and Vendors: Drive supplier technical alignment, capability development, and delivery performance.
Finance: Support CapEx planning, forecasting, and reporting.
EHS Teams: Ensure machine safety, ergonomics, environmental compliance, and risk mitigation.
RESPONSIBILITIES:
1. Process & Equipment Strategy, Design and Development
Provide technical ownership and strategic direction for assembly, packaging, automation, inspection, molding, press, and manufacturing equipment.
Translate business, product, quality, and capacity requirements into robust end-to-end equipment and automation strategies.
Define, create, review, and approve User Requirement Specifications (URS) ensuring clear translation to supplier designs and site needs.
Lead the development and evaluation of multiple technical concepts, architectures, and solutions considering risk, scalability, standardization, lifecycle cost, and validation impact.
Develop innovative mechanical and automation concepts aligned with BD standards, industry best practices, and emerging technologies.
Review and approve mechanical, electrical, and controls architectures, layouts, 3D models, 2D drawings, and system interfaces.
Provide expert oversight of engineering analyses and simulations (stress, strain, thermal, airflow, cycle time) to validate and optimize designs.
Lead and approve design reviews, machine safety reviews, risk assessments, and FMEA activities.
Support and lead Proof of Concept (POC) activities and Design of Experiments (DOE) to define process windows and establish baseline performance.
Verify and approve relationships between KPIVs and KPOVs and ensure process capability is demonstrated.
Optimize equipment and process designs to improve performance, reliability, ergonomics, changeover time, maintainability, manufacturability, and total cost of ownership.
Provide authoritative technical and cost input to capital justification (CB-2) including risk, validation effort, and sustainability of performance.
2. Supplier, Vendor & Capital Program Leadership
Act as technical lead for supplier and system integrator engagement on large or complex capital programs.
Lead and approve vendor selection, RFQs, and technical evaluations in partnership with Procurement.
Define and control supplier technical scope, interfaces, cost, lead time, risks, and performance expectations.
Review and approve supplier designs, specifications, safety concepts, automation architecture, and documentation.
Lead, witness, and approve Factory Acceptance Tests (FAT) including acceptance criteria, deviation management, and corrective actions.
Oversee supplier issue resolution, design changes, and continuous improvement actions.
Support contract execution, change management, and claims resolution with Procurement and Legal.
Establish and maintain strong long-term technical relationships with strategic equipment suppliers.
3. Equipment Integration, Validation & Start-Up
Provide technical leadership for end-to-end equipment integration into operating manufacturing environments.
Approve and oversee installation, integration, and commissioning strategies including site readiness, utilities, layout, logistics, and EHS compliance.
Lead and approve SAT, commissioning, qualification, and validation strategies.
Ensure execution of equipment qualification, process verification, and process validation in compliance with regulatory and quality requirements.
Approve validation protocols, reports, and acceptance decisions.
Lead and support vertical start-up ensuring equipment, process, documentation, materials, and personnel readiness.
Act as escalation point for complex integration, automation, and performance issues.
4. Ramp-Up, Performance & Continuous Improvement
Ensure achievement and sustainability of OEE, yield, throughput, scrap, reliability, and capacity targets during ramp-up and early production.
Lead and approve center lining strategies to stabilize and optimize long-term equipment performance.
Oversee performance gap analysis between expected and actual results and drive corrective action plans.
Champion Continuous Improvement (CI) initiatives leveraging Lean Manufacturing, data analytics, and standardization.
Drive lessons learned, best practices, and technology reuse across sites and programs.
5. Documentation, Training & Handover
Ensure completeness and quality of all equipment and validation documentation, including URS, specifications, drawings, FAT/SAT reports, qualification/validation records, maintenance and control plans, spare parts lists, and software backups.
Approve operating instructions, troubleshooting guides, standard work, and maintenance procedures.
Ensure site training and capability transfer is completed prior to handover.
Approve formal handover to Operations, Maintenance, Engineering, and Quality functions.
6. Compliance, Safety & Quality Leadership
Ensure full compliance with EHS, machine safety, ISO, FDA, GMP, and BD Quality System requirements.
Act as technical authority during audits, inspections, and regulatory interactions related to equipment and processes.
Promote and model a strong safety, quality, and compliance culture across all projects.
7. Technical Leadership & Mentoring
Serve as a senior technical authority and subject matter expert within GIE EDI.
Mentor and develop engineers across levels, providing technical guidance and coaching.
Lead complex technical discussions and decision-making across global, cross-functional teams.
Drive global standardization, harmonization, and knowledge sharing initiatives.
Required Qualifications:
Bachelor’s Degree in Engineering (Mechanical, Electrical, Controls, Automation, Manufacturing, or related field), or equivalent experience.
8 years of progressively responsible experience in equipment design, automation, manufacturing engineering, and capital project delivery.
Extensive experience integrating equipment in complex, regulated manufacturing environments with strong focus on validation and vertical start-up.
Proven leadership in large or complex capital projects.
Demonstrated expertise in Lean Manufacturing, DOE, SPC, FMEA, and structured problem solving.
Willingness and ability to travel internationally as required by project needs.
Preferred Qualifications:
Experience in an FDA regulated quality environment desired.
Knowledge and Skills:
Strong ability to synthesize data, risks, and technical information into clear recommendations.
Recognized technical authority in manufacturing equipment and automation systems.
Strong capital program and stakeholder management capabilities.
Exceptional analytical, problem-solving, communication, and presentation skills.
Ability to influence without authority across global organizations.
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 UT - SandyAdditional 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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