Verification Engineering Manager
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.
The Verification Engineering Manager is the primary Subject Matter Expert (SME) for execution of engineering and verification testing activities for the development team. The Verification Engineering Manager will manage customer sample builds, test sample builds, device related component qualifications, engineering and verification testing activities, and equipment required for verification testing. The individual will bring excellent analytical, engineering, and organizational talent to the execution of development projects at West.
PRIMARY DUTIES AND RESPONSIBILITIES:
Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
Provide strong leadership to the development team in leading the effort to execute engineering and verification testing activities for a product (or product family).
The Engineering Verification Manager is responsible for the the development of test plans with input for the Engineering Team to assure that the necessary test are available to challenge technical requirements in the PRM.
The Engineering Verification Manager is responsible for the the development of Protocols and Reports with input from the Engineering Team required for Engineering Testing, Human Factors Engineering, Design Verification and Design Validation.
Assure the appropriate analysis techniques, analysis results, and graphical outputs are used and included in reports throughout the development process.
Assure all engineering test fixtures, assembly fixtures, test methods, assembly methods have gone thru the appropriate level of Gauge R&R and Qualification throughout the development process.
Participate in the Development of initial project scope, timeline, savings and cost estimations.
Works with the Project Manager to assure adherence to the development schedule.
The Verification Engineering Manager must have excellent problem solving skills as well as keen analytical abilities.
They must have strong leadership qualities, as well as excellent communication skills.
Ensure development activities are in compliance with QMS, OSHA, local, state and federal environmental regulations.
Improve processes and procedures to develop high quality products at a minimum cost.
Promote and support an agile and lean development process.
Write CER and project justification documents as required.
Present justification to management and/or customer to attain approvals.
Performs other duties as assigned based on business needs.
Exhibits regular, reliable, punctual and predictable attendance.
Provide leadership to the development team.
Education: Bachelor's in Engineering is preferred.
Experience: 8-10 years of experience
3+ years of managerial or supervisory experience preferred.
Knowledge of Design Controls, Statistics, Engineering Principles, Test Method Development, Gage R&R, Human Factors Engineering, Design Verification / Validation, and Manufacturing.
Knowledge of ISO-11608, IEC-6061 and other relevant standards for medical devices.
Must have effective problem solving and interpersonal skills
Six sigma black belt preferred.
Strong background in R&D with electromechanical development a plus.
PHYSICAL & TRAVEL REQUIREMENTS:
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 disability or special need that requires accommodation, please send an email to firstname.lastname@example.org. 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.
West Pharmaceutical Services