United States, Pennsylvania, Mechanical Inspector jobs

As the Global Equipment Compounding & Dimensioning Subject Matter Expert (SME) Leader, you will set the strategic direction and lead a team responsible for specifying, implementing, and improving equipment for weighing, mixing, and dimensioning processes in our global elastomer production facilities. You will cultivate a collaborative environment, align with cross-functional engineering teams, and drive our company’s vision for innovation and standardization in equipment processes.

• Inspire and guide the Global Compounding & Dimensioning Equipment SME team (up to 3 FTE) towards achieving organizational goals. Develop a high-performing team through mentoring and professional development.
• Lead engineering, management, plant operations and global team members while working with vendors to develop engineering specifications for new equipment or required improvements on existing.
• Shape and communicate a clear vision for advancing equipment processes, leading efforts to standardize and harmonize production equipment and associated documentation globally.
• Proactively map out and oversee team workload and project timelines to drive efficient execution of objectives, with a focus on resource optimization for new projects, corrective action/preventive action (CAPA) initiatives, and equipment development.
• Foster a culture of collaboration across various departments by working closely with Process Engineering and production teams. Facilitate the identification of innovative solutions to enhance existing systems and solve design challenges.
• Keep up to date on new and future equipment standards and trends in the market and identify value-added improvement which may be beneficial.
• Work independently, and with vendors, to understand root cause of failures, propose design or component changes, and implement and validate equipment modifications.
• Take the lead in systematic problem-solving activities if the manufacturing plants need support.
• Coordinate and/or execute all necessary GMP related validations and/or process engineering evaluations as needed for manufacturing equipment.
• Guide vendors through clear communication and task assignments. Maintain oversight on deliverables ensuring completion of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation/Operational Qualifications (IOQ), and more.
• Champion the establishment of equipment standards aligning with global best practices to achieve unparalleled quality, efficiency, cost reduction, and safety.
• Project Management: Take the lead on equipment project management from the URS issue to PQ by applying current project managements practices including the needed GMP conform documentation.
• Research and analyze data such as vendor design proposal, specifications, and manuals to determine feasibility of design or application.
• Collaborate with cross-functional teams to follow equipment related corporate goals.
• Ensure all equipment aligns with the latest Safety Regulations.

• Bachelor’s or Master’s degree in Science or Engineering (Electrical, Mechanical, or Industrial preferred).

• Over 8 years of leadership experience in the pharmaceutical or manufacturing environments, specifically within equipment management and improvement.

• Proven track record of successful equipment project management, from specification to qualification.
• Strong engineering and trouble shooting skills.
• Proven working experience in project management.
• Demonstrated ability to manage projects in a dynamic environment with minimal direction.
• Excellent written and verbal communication skills (English & preferably a 2nd language)
• Strong strategic thinking capabilities with the ability to drive innovation and embrace change.
• Ability to drive changes and to think outside the box.
• Track record of project management excellence and great ability to perform in dynamic, autonomous environments.
• Exceptional communication skills, both in client-facing scenarios and within internal teams.
• Strong in Project and Time Management.
• Outstanding leadership and organizational skills.
• Working experience with Microsoft office products, Power BI, SolidWorks and/or other CAD systems.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• 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