דרושים Process Engineer ב-United States, Pennsylvania, Williamsport

• Interacts with all departments pertaining to implementation of statistically established studies either for process improvements or establishment thereof.
• Ensure quality of all materials used in the process by developing and implementing effective reliable testing techniques.
• Ensure continued reliability of testing techniques by maintaining current knowledge of all technical and analytical information.
• Write technical reports as required to defend or support decisions concerning material acceptability.
• Establish and implement reliable procedures to ensure compliance with good manufacturing practices.
• Provide project leadership for materials / process related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget.
• Support the efforts of production in materials related areas as a technical advisor.
• Reviews data using InTouch and eDart software, for investigation of problems.
• Take appropriate action to ensure compliance with all safety, health and hazardous communication standards.
• Ensures that established policies, rules and regulations, and procedures are followed.
• Actively participate and comply with all West HSE programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Associate or Bachelor’s Degree or equivalent on the job experience in a technical discipline to include manufacturing, industrial, materials or plastics.

• Experience: 3-5 years of job-related experience
• Knowledge of the basic principles of injection molding, systematic molding, mold design, mold assembly, and machine operations.

• Must have excellent interpersonal & problem-solving skills & be able to interface with employees at all levels of the organization; must possess good organization, time-management, negotiating & conflict resolution skills.
• Must be familiar with computers and various software programs.
• Familiarity with SAP, Master Control or similar systems and databases, a plus.
• Knowledge of statistical tools and Minitab.

• 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
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Manufacturing\Six Sigma Green Belt Certification preferred

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required as posted in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

• Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
• As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
• The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
• Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
• Perform the necessary functions in support of the Williamsport Quality System
  • Designated ISO 13485 Management Representative
  • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
• In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
• QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
• Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
• Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
• Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
• Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
• Responsible and accountable for quality departmental budget
• Other duties as assigned

• Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
• Master’s degree preferred

• 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
• 8+ Years of supervisory experience required.
• 5+ Years of experience working with injection molding processes preferred.
• 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
• Self-motivated with a proactive attitude and the ability to work effectively
• Project Management experience preferred

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• 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 multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy

The Process Technician is responsible for safely implementing, optimizing, and sustaining injection molding processes, molds, and equipment to consistently produce high-quality products for our customers. The role requires strict adherence to all safety, and processing protocols. The Process Technician must maintain a clean and safe work environment per the West 6S program, perform regular preventative maintenance, and assume material handling duties as needed. Additional responsibilities may be assigned to support operational objectives.

• Maintain the injection molding process definition for all jobs.
• Utilize statistical analysis of process data, along with troubleshooting techniques, to redefine and improve processes that fail to meet established product criteria.
• Properly document corrective actions using Good Documentation Practice standards (GDP).
• Ensures that established policies, rules, regulations, and procedures are followed.
• Effectively communicates between all departments.
• Safely and properly installs tooling and applicable auxiliary equipment.
• Completes all prerequisite tasks and documentation for starting a production tool.
• Effectively perform scheduled preventative maintenance of tools and equipment.
• Actively participate and comply with all West Health Safety Environment (HSE) programs and regulations.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Compliance with the company’s quality policy at all times.
• Additional duties as assigned.

• High School Diploma or GED required

• Minimum 3 years experience in a mechanical related field.
• Preferred: Minimum 3 years of injection molding – machine start up and shut down – mold pull / set activities – Setup and operation of 3 axis robots.

• Ability to analyze details and strong problem-solving abilities.
• Strong communication and teamwork skills.
• Ability to interpret and apply work instructions.
• Ability to obtain a Powered Industrial Truck (PIT) license.
• Ability to read mechanical diagrams and schematics.
• Ability to read and interpret technical drawings, blueprints, and process control documentation.
• Possess a fundamental mechanical aptitude of mechanical principles and concepts.
• Proficient with Microsoft Office.
• Demonstrated ability to perform root cause analysis to identify and address underlying issues in production processes, improving efficiency and product quality.

Coordinate planning and execution of all processing needs and issues. Direct and coordinate activities of the technicians. Communicate with Area Manager, Manufacturing Supervisor and/or Supervisory Designee

• Coordinate technical activities for the shift to include monitoring of quality, human resource allocation, supply and housekeeping.
• Plan daily activities of technical group and communicate processing concerns that will influence the daily schedule to management.
• Gathering of valid production data and reporting to management.
• Creation and maintenance of a positive work environment.
• Training of employees on Process Monitoring Systems or other information systems.
• Coordinates activities of shift technical group to include process implementation, process maintenance, designs of process, capability studies and housekeeping.
• Maintains pertinent files on processes necessary for future referral.
• Institutes and ensures implementation of training programs to ensure personnel are proficient in performance of assigned duties.
• Takes appropriate action to ensure compliance with all safety, health and hazardous communication standards.
• Ensures that established company policies, rules, regulations, and procedures are followed.
• Training and certification on related employee procedures.
• Support of management decisions.
• Actively participate and comply with all West HSE programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Bachelor’s degree in Engineering in manufacturing, industrial, materials or plastics or
• Associates degree in Engineering in manufacturing, industrial, materials or plastics with a minimum of five (5) years of hands on experience in a manufacturing environment.

• 10 years of hands on experience in a technical supervisory role in a manufacturing environment, preferably plastic injection molding industry.
• 2-3 years of leadership experience. required
• Knowledge of the basic principles of injection molding, systematic molding, mold design, mold assembly, and machine operations.

• Must be familiar with computers and various software programs.
• Familiarity with SAP, Master Control or similar systems and databases, a plus.
• Excellent communication and interpersonal skills.
• Good analytical skills.
• Ability to work both independently with little direction, and as a member of a team.
• Ability to manage several projects at once to meet established timelines is essential.
• Ability to read electrical, mechanical, and hydraulic/pneumatic drawings is essential
• Some understanding of the injection molding process

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required at all times in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.

• Designing and implementing Business Intelligence (BI) solutions throughout the organization.
• Establishing and developing relationships with key internal stakeholders to understand the distinct BI needs across all business departments and support the service delivery.
• Building and preserving productive relationships with a broader business network, IT associates, and vendors, while addressing and resolving potential issues.
• Aiding in the creation of a uniform approach towards the execution of BI projects.
• Overseeing multiple BI projects, ensuring smooth progression from inception to completion.
• Offering maintenance services for existing BI solutions and serving as the primary escalation point for issues related to BI projects.
• Bridging the gap between business necessities and technical considerations, negotiating solutions, and encouraging creativity when feasible.
• Contributing to the ongoing growth and delivery of BI services, inclusive of projects, while ensuring constant protection and security of business data.
• Define and translate business rules and processes into S4 Hana data solutions
• Lead projects impacting data integration for manufacturing KPI’s
• Providing guidance, templates, reporting and instructions to Supply Chain, Operations, Quality, Warehousing and Finance regarding the required maintenance of Master Data and transactions.
  • E.g. Tier meeting dashboards, reports such as OEE, scrap, sales & absorption
• Supporting equipment interfacing needs.
  • E.g. Intouch & Edart MRP’s
• Supports and continuously improves procedures and processes related to but not limited SAP S4 Hana & Power Bi.
• Other duties as assigned.

• Bachelor's Degree in Engineering or another scientific area or equivalent experience required

• Related SAP & Power BI Work Experience: Minimum 5 years of experience
• A minimum of 5 years’ experience in a Business Analyst role or a similar position with relevant experience.
• Experience in delivering or managing BI projects.
• Familiarity with high-volume manufacturing operations.
• Proven ability to manage multiple projects simultaneously, demonstrating excellent multitasking and prioritization skills.
• Proficiency in translating technical language into comprehensible terms.
• Experience in implementing, configuring, and testing BI solutions.
• Experience in developing within the Microsoft Power Platform environment, with a focus on Power BI, Power Automate, and Power Apps.
• Working knowledge of Microsoft Power BI Desktop, management of Microsoft Teams groups, OneDrive storage, and Microsoft SharePoint.
• Proficiency in using Microsoft 365 applications, with an understanding of its interconnections with Microsoft SharePoint and Microsoft Power Platform.
• Experience in data extraction, cleansing, and integration.
• Understanding of Lean Manufacturing principles, such as Value Stream Maps, Continuous Improvement, and Kaizen.

• Good knowledge of LEAN and 6 sigma manufacturing principles
• Knowledge of statistical tools and Minitab
• cGMP knowledge
• 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
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company's safety and quality policies at all times

• Manufacturing\Six Sigma Green Belt Certification within 1 Year required

• Self-motivated, results- and solution-oriented personality
• Very good organizational and project management skills
• Highly analytical and structured way of working
• Ability to successfully collaborate with teams across different countries and organizational levels
• Fluent in English
• Proficient in Microsoft based programs
• Ability to assert technical solutions and standards in an international environment
• Excellent communication skills and ability to collaborate well with people across different countries
• Manage working with colleagues in different time-zones
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• 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 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

The Process Engineering Manager will lead the engineering team responsible for developing, optimizing, and maintaining robust injection molding processes for medical device manufacturing. This role requires deep technical expertise in injection molding and process validation within a regulated, high-precision environment. The ideal candidate will ensure compliance with ISO 13485, and GMP requirements, while driving continuous improvement in quality, efficiency, and cost.

• Lead and manage a team of process engineers, process engineering technicians, and validation technicians.
• Develop, validate, and optimize molding processes using scientific molding techniques to ensure high-quality, repeatable manufacturing outcomes.
• Oversee process validation activities (IQ/OQ/PQ) in compliance with ISO 13485 requirements.
• Drive continuous improvement initiatives using Six Sigma, Lean Manufacturing, and other methodologies.
• Interface with Quality and other teams to support new product introductions (NPI) and design for manufacturability (DFM).
• Mentor and develop engineering talent; set performance goals and conduct regular reviews.
• Serve as the primary technical liaison between internal teams and external customers.
• Provide technical support and updates on project timelines, process readiness, and validation status to customers.
• Act as the primary engineering contact for customers during new project development, trials, and production scale-up.
• Review production and operating reports and resolve operational and manufacturing problems to ensure minimum cost and prevent operational delays.
• Develop or revise standard operational and working practices and monitor operations to ensure compliance with standards.
• Support the Sales team with engineering resources to support quoting activities.
• Actively participate and comply with all West HSE and OpEx programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Bachelor’s degree in Mechanical, Plastics, or Manufacturing Engineering.

• Minimum 8 years of experience in injection molding, with at least 3 years in a leadership or management role.
• Proven experience working in the medical device industry with a strong understanding of regulatory requirements (FDA, ISO 13485, GMP) would be an advantage.
• Expertise in scientific molding, process validation, and statistical process control.

• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.

• Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage.
• Knowledge of Lean and 6 Sigma Manufacturing

• Excellent communication skills (in English)
• Ability to assert technical solutions and standards in an international environment
• Ability to collaborate well with people across different countries
• Self-motivated, results- and solution-oriented personality
• Ability to work independently
• 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
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• 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 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

The Process Technician is responsible for safely implementing, optimizing, and sustaining injection molding processes, molds, and equipment to consistently produce high-quality products for our customers. The role requires strict adherence to all safety, and processing protocols. The Process Technician must maintain a clean and safe work environment per the West 6S program, perform regular preventative maintenance, and assume material handling duties as needed. Additional responsibilities may be assigned to support operational objectives.

• Maintain the injection molding process definition for all jobs.
• Utilize statistical analysis of process data, along with troubleshooting techniques, to redefine and improve processes that fail to meet established product criteria.
• Properly document corrective actions using Good Documentation Practice standards (GDP).
• Ensures that established policies, rules, regulations, and procedures are followed.
• Effectively communicates between all departments.
• Safely and properly installs tooling and applicable auxiliary equipment.
• Completes all prerequisite tasks and documentation for starting a production tool.
• Effectively perform scheduled preventative maintenance of tools and equipment.
• Actively participate and comply with all West Health Safety Environment (HSE) programs and regulations.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Compliance with the company’s quality policy at all times.
• Additional duties as assigned.

• High School Diploma or GED required
  • Associate’s degree in Plastic & Polymer Education preferred but not required
  • RJG or similar injection molding training a plus

• At least 3 years of injection molding – machine start up and shut down – mold pull / set activities – Setup and operation of 3 axis robots.

• Proficiency with a variety of production equipment, and hand tools.
• Ability to analyze details and strong problem-solving abilities.
• Strong communication and teamwork skills.
• Ability to interpret and apply work instructions.
• Ability to obtain a Powered Industrial Truck (PIT) license.
• Ability to read and interpret technical drawings, blueprints, and process control documentation.
• Possess a fundamental mechanical aptitude of mechanical principles and concepts.
• Proficient with Microsoft Office.
• Demonstrated ability to perform root cause analysis to identify and address underlying issues in production processes, improving efficiency and product quality.