דרושים United States, Pennsylvania, Planner ב-United States

Responsibilities:

Assist in process optimization projects for the regulatory affairs area (e.g. database maintenance, regulatory controls, automation).
Perform data analysis and report findings.
Process mapping to identify areas for optimization and automation

Requirements

Desirable skills or interests:

skills to clean and preprocess data to ensure its accuracy and consistency;
Interests in programming languages, scripts for task automation, database management

About the Role:

At Boston Scientific, the Supply Chain Planner I support the Clinical Supply Chain (CSC) organization by supporting the device distribution and tracking of investigational products from the trial planning phase through final reconciliation of products. This role involves coordinating with internal and external groups to meet clinical trial deliverables while ensuring regulatory compliance. Responsibilities include demand planning, data analysis, inventory management, document tracking, and ensuring clinical objectives are met within time, budget, and compliance parameters.

Your Responsibilities Include:

• Partner with other Clinical Supply Chain team members to complete and approve the Device Management plan prior to the start of study enrollment.
• Participate in the Device Management system user acceptance testing.
• Assist in developing demand plans and ensuring appropriate and timely supply for clinical trials.
• Engage with clinical team, customer care, distribution, and logistics teams to ensure product is distributed in a timely and compliant manner for clinical trials.
• Engage with external groups/vendors, when used, to ensure distribution and processes are in place to support on time enrollment within compliance.
• Monitor trial performance and inventory position as to reduce excess, expired and obsolete inventory (EE&O) risk.
• Using data models and device accountability systems to analyze and ensure that investigational devices are tracked throughout the clinical trial.
• Collaborate with internal and external groups to return and track un-used product into our distribution centers and to final device disposition.
• Support Vendor Management activities with existing or new trials.
• Escalate issues and potential risks to CSC management as applicable.

Qualifications Required:

• Bachelor’s degree in supply chain or equivalent work experience required.
• Strong Analytical skills with ability to structure and perform data analysis.
• Experience solving urgent and complex business challenges.
• Excellent communication and relationship management skills.
• Strong Organization skills to work multiple issues in parallel over time.
• Strong PC skills, including Excel, Word, and Power Point.
• Adhere to procedures and practices that maintain compliance to regulations.

Qualifications Preferred:

• Medical devices/pharmaceutical clinical trials and device distribution experience preferred.
  Sales, Inventory, and Operations Planning (SI&OP) experience is a plus.
• Experience utilizing SAP or other ERP system preferred.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

About the Role:

The Senior Financial Analyst will provide financial support to the Interventional Oncology & Embolization organization. The ideal candidate will have strong analytical, communication, and organizational skills. The position requires someone that can build strong relationships with business partners to optimize financial planning, analysis, and reporting. Additional responsibilities include leading financial reviews and facilitating month-end close.

Key Responsibilities:

• Partner independently with business partners and functions
• Develop detailed financial forecasts incorporating historic, trended, and current business information
• Monitor functional and departmental spending versus budget by highlighting material variances using system generated detail and trend reports
• Prepare and distribute financial metric packages by gathering and analyzing information related to current performance
• Present to upper management & business partners and provide guidance on variances and trends
• Perform financial analysis and recommend alternative courses of action by utilizing appropriate financial tools and creative problem solving
• Prepare journal entries and assist in month end close as needed to ensure proper accounting at the functional and departmental level
• Develop and utilize sound financial processes and maintain effective control environment

Minimum Qualifications:

• Bachelor’s degree in Finance or Accounting
• 3-5 years relevant experience
• Strong attention to detail and data quality
• Strong financial analysis, communication, and prioritization skills
• Ability to develop and maintain business relationships with strong service orientation
• Ability to multi-task, set priorities, and adhere to deadlines in a high-paced organization
• Advanced Microsoft Excel and PowerPoint required
• Team orientated

Preferred Qualifications:

• MBA or CPA a plus
• Hyperion (Oracle) and SAP a plus

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Your responsibilities will include:

• Serve as a key point of contact for production units, sister sites, and global supply chain partners during SIOP and SIOE planning processes.

• Provide strategic direction on manufacturing priorities to cross-functional stakeholders.

• Proactively identify and resolve material shortages impacting build plans.

• Identify opportunities and lead projects to improve service levels, build plan adherence, on-time delivery, and inventory optimization.

• Manage WIP and subassembly inventory for assigned production areas.

• Train team members and associates on planning and materials management processes.

• Maintain and manage master data elements including safety stock, yields, lead times, and more.

• Conduct inventory analysis and create recovery plans as needed.

• Perform “what-if” scenario planning to support decision-making.

• Actively lead and support continuous improvement and Lean initiatives.

• Collaborate with cross-functional teams on product lifecycle management activities.

• Work independently on complex projects with long-range impact.

• Interface with senior leadership on high-visibility initiatives and planning decisions.

• Provide departmental leadership support and assist manager with team direction.

Required qualifications:

• Bachelor’s degree required

• Minimum of 5 years’ experience in manufacturing planning, inventory control, demand planning, or a supply chain function

• Proven experience with the Sales, Inventory & Operations Planning (SIOP) process

• Hands-on experience with ERP systems (SAP preferred) and MRP tools

• Proficiency in Microsoft Office Suite: Teams, Outlook, Excel, and PowerPoint

Preferred qualifications:

• Experience with advanced planning systems (APS), such as Kinaxis RapidResponse

• Background in planning within vertically integrated manufacturing environments

• APICS certification (CPIM or CSCP)

• Experience leading continuous improvement projects or managing cross-functional initiatives

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Job Respondsibilities:

• To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives

• Engineering process owner for the area

• Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.)

• Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives

• Develop and modify various manufacturing processes to improve product and process quality and output

• Ensure product/process requirements are met for component, assembly, tooling and supplier specifications

• Perform product/process/vendor qualification activities as required

• Support material discrepancy review and disposition activities (MRB) for existing commercial products

• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company

• Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts.

• Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals

• Capable of training cross functional team members including, engineers, technicians and product builders

• Knowledge of project management

• Interacts cross functionally and with internal and external customers

• Ability to develop expert knowledge on BSC systems.

• Willing to travel internationally as part of project team.

• For individual who is assigned calibration engineering role only:

• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.

• Technical SME for Calibration group and SME for internal and external Audit

• SME for Calibration Management System

• Manage and Perform calibration functions.
• Sets day to day function for calibration group

• Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required.

• Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures.

• Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques.

• Provides support and guidance to calibration technicians in performing complex equipment calibrations.

• Manage calibration lab needs regarding such issues as environmental control and new technologies.

• Works with Senior Metrology Engineer and Management to develop the department fiscal year budgets.

• Communicates with the Operations ME function on calibration status.

• Build Quality into all aspects of work by maintaining compliance to all quality requirements

Job Requirements:

• Candidate required possess at least Bachelor's Degree in Engineering.

• Required at least 5 ~ 7 years of working experience in manufacturing or process engineering.

• Proven track record in product transfers, equipment qualification, and process validation.

• Experience in working within a matrix organization and cross-site collaboration.

• Able to work under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new product.

• Prefer candidate with strong project management and technical documentation skills.

• Proficient in validation protocol/report writing (IQ/OQ/PQ).
• Skilled in root cause analysis and process improvement method.
• Effective communication and stakeholder management across global teams.