דרושים Director Mechanical Engineering ב-West Pharma ב-United States, Scottsdale

• Direct mechanical engineers in design activities including ideation, prototyping, performance testing & analysis, design selection, requirement setting, and change requests.
• Develop and drive drug delivery device mechanical engineering strategy and identification of key capabilities needed for scale and growth.
• Provide technical oversight of team outputs including mechanical systems models, CAD models, 2-D dimensioned drawings, tolerance analyses, feature function maps, and mechanical dFMEAs.
• Develop and drive team to maintain and improve on team key performance indicators including schedule adherence, complaint & non-conformance reduction, and on target to budgeted spend.
• Interface with customers and external support services, e.g. suppliers and contract vendors, to facilitate the development and execution of assigned programs, as well as the development of technical services capability and capacity to meet future R&D needs.
• Select, develop, and manage global technical team ranging from early career to senior manager level to meet current and future needs.
• Build and maintain strong relationships with customers, business partners, functional leaders, and other senior level executives.
• Support platform product development and sustainment strategy including product and process improvement roadmaps.
• Participate in industry forums and standards committees as a West representative.
• Perform other duties as assigned based on business needs.
• Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.

• Bachelor's degree in Engineering or othertechnical related field, or equivalent experience required
• Master's degree in Business Administration or Engineering preferred

• Minimum 10 years of experience in mechanical design or engineering capacity required
• Minimum 3 years experience in a leadership role required.

• Demonstrated ability to:
  • Lead, prioritize, and complete multiple technical projects and daily tasks.
  • Lead and mentor others.
  • Facilitate and coach others through effective problem solving and decision making processes.
  • Understand and communicate technical ideas and concepts with technical and non-technical audiences (written and verbal).
  • Delegate and empower others while maintaining accountability to overall functional performance.
  • Work well with others in a variety of situations.
• 5+ years of medical device and/or drug delivery system product development experience.
• Background in development or sustainment of electromechanical products.
• Broad experience in product development from early feasibility through commercialization and into sustainment including design controls, statistics, test method development, gauge R&R, human factors engineering, design verification, and design validation.
• Proficiency in GD&T, tolerance analysis methods, and finite elemental analysis (FEA).
• Proficiency in SolidWorks, CETOL, SAP ECTR, MS Office Suite, Minitab, and DevOps.
• Experience influencing business and technical teams to adopt alternative ideas and methods.
• Knowledge of injection molding industry and respective processes

In this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

• Responsible for the development and execution of sterilization strategies to ensure medical devices meet functionality and design standards.
• Perform risk assessments and validation studies to ensure the effectiveness and safety of sterilization methods and protocols.
• Develop, maintain, and update sterilization processes in compliance with industry standards and regulatory requirements.
• Work with R&D, Quality Engineering, and other departments to ensure product integrity during product introductions, sustaining changes, and transfers.
• Offer technical support and insight regarding sterilization processes and regulations to internal and external stakeholders.
• Analyze and monitor data to identify trends, driving improvements in sterilization processes.
• Identify, investigate, and resolve issues related to sterilization equipment and processes efficiently.
• Participate in audits to ensure compliance with regulatory standards, providing recommendations for continuous improvement.
• Train and mentor R&D teams on sterilization processes, procedures, and regulatory requirements.
• Oversee the commissioning, maintenance, and validation of sterilization equipment to meet operational and energy efficiency standards.
• Identify and drive process improvements initiatives and cost-saving opportunities related to sterilization systems.
• Manage regulatory filings and respond to inquiries from regulatory bodies concerning sterilization processes.
• Deliver progress reports and presentations to communicate activities and timelines to management and core team members.
• Adhere to West compliance and safety policies and procedures at all times.
  

• Bachelor's in Microbiology, Biomedical Engineering, or Chemical Engineering or related engineering disciplines required
• Masters Degree in related field preferred

• 5+ years of experience in development of sterilization, medical devices, or pharmaceuticals.
• Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities) required.
• Experience leading sterilization development workstreams from concept through commercialization.
• Experience in working under requirements of Quality Management System in a regulated environment.
• Must have effective problem-solving abilities.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Able to comply with the company’s safety policy at all times.