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Title:  Sr. Engineer, R&D, Verification, Scottsdale

Requisition ID:  20462
Date:  Oct 21, 2021
Location: 

Scottsdale, Arizona, US

Department:  R&D
Description: 

Sr. Engineer, R&D, Verification, Scottsdale   

Scottsdale

Arizona    

 

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 $1.84B in 2019. 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 with Without Borders team member-led giving program.

 

Job Summary:

In this role, you will

 

Essential Duties and Responsibilities:

  • Demonstrates a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Offers strong leadership to the development team in leading the effort to execute engineering and verification testing activities for a product (or product family).
  • Responsible for the development of test plans with input from the Engineering Team to assure that the necessary tests are available to challenge technical requirements in the Product Requirements Matrix (PRM).
  • Responsible for the development of Protocols and Reports with input from the Engineering Team required for Engineering Testing, Human Factors Engineering, and Design Verification. 
  • Assures the appropriate analysis techniques, analysis results, and graphical outputs are used and included in reports throughout the development process.
  • Responsible for the development of test methods, as well as the planning and coordination of test method validations/Gage R&Rs. Assures all engineering test fixtures, assembly fixtures, test methods, assembly methods have gone through the appropriate level of Gauge R&R and Qualification throughout the development process.
  • Works with the Verification Engineering Manager and Project Manager to assure adherence to the development schedule.  Participates in the development of project scope, timeline, savings and cost estimations.
  • Ensures development activities are in compliance with the global WEST Quality Management System (QMS), OSHA, local, state and federal environmental regulations.
  • Recognizes inefficiencies and takes initiative to improve processes and implement procedures to streamline workflows and increase effectiveness. 
  • Promotes and supports an agile and lean development process.
  • Writes CER and project justification documents as required.
  • Presents 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.

 

Basic Qualifications: 

  • Required minimum education: Bachelor’s degree in engineering discipline (or equivalent experience)
  • Required minimum experience: 5-8 years of experience

 

Preferred Knowledge, Skills and Abilities:

  • Strong leadership qualities and should be able to provide training or mentorship to lower level engineers.
  • Excellent communication and interpersonal skills.
  • Excellent problem-solving skills as well as keen analytical abilities.
  • Expertise in Design Controls, Statistics, Engineering Principles, Test Method Development, Gage R&R, Human Factors Engineering, Design Verification / Validation, and Manufacturing.  
  • Strong background in R&D with experience in electromechanical device a plus.
  • Experience testing medical devices in accordance with FDA regulations.
  • Knowledge of ISO 11608: Needle-based injection systems for medical use
  • Six sigma black belt preferred.
  • Proficiency in CAD (SolidWorks).
  • Strong technical writing skills.
  • Able to comply with Good Laboratory Practices (GLP)
  • Able to comply with the company’s safety and quality policy at all times

 

Travel Requirements:

  • Must be able to travel up to 10% of the time.

 

Physical & Mental Requirements:

  • Must be able to perform job duties as required with limited physical demands.

 

 

 

 

 

 

 

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 peggy.tayloe@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.

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