Title:  Sr. Manager Engineering

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

In this role, The Senior Manager of the   Engineering team will lead and build a dynamic team that supports new product development and existing products across the organization. This position will manage product and process improvements initiatives by collecting, compiling and analyzing data. Coordinates activities associated with continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities. Represents   Engineering for both internal and external projects, which originate from both corporate and manufacturing facilities. Develops procedures for applicable   systems or process across the Scottsdale.

Essential Duties and Responsibilities:

• Manage at team of 10+   Engineers to support new product development, sustaining customers, product transfers, product and process improvements as well as global engineering activities.
• Organize and generate detailed   information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall   of a project and deliver key metrics to assess the overall effectiveness of the test engineering group.
• Work with project managers, engineering team, and platform management to develop plans to implement   Improvement Program (QIP) workstream activities.
• Manage or work as a member of project teams to develop design control deliverables including   plans, manufacturing & inspection documentation, test methods, and any necessary records for compiling design history file.
• Assesses Critical To (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow.
• Manage or in some cases perform design control activities requiring judgement in the planning, evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures, and criteria. 
• Ensures teams work closely with product development, supplier/contractors, design, regulatory teams in order to establish specifications and validation(V&V) plans.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• Support   assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• Work within   or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• All other duties as required.

Basic Qualifications: 

• Bachelor’s degree in Science, Engineering, or related field
• Experience: 8-12 years

Preferred Knowledge, Skills and Abilities:

• Minimum of 8 years’ experience in pharmaceutical or medical device manufacturing environment; minimum 4 years’ experience in a   Engineering role; ASQ CQE certification desirable.
• Deep knowledge of   processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred
• Support and contribute in 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   policy at all times.

Travel Requirements:

• 15% travel may be required

Physical & Mental Requirements:

• Work in a manufacturing environment, subject to heat and cold as well as loud noise
• Work in an office environment. At times must sit for extended periods of time
• Ability to effectively communicate and comprehend complex ideas and concepts
• Use written and oral communication skills
• 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
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Maintain high attention to detail, accuracy, and overall   of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

Competencies/Authorities

• Non-US only where required for certain levels

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.