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Title:  Sr System Engineer

Requisition ID:  41345
Date:  May 6, 2022
Location: 

Scottsdale, Arizona, US

Department:  R&D
Description: 

 

 

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, you will support the design and development activities of West’s proprietary medical devices under development which is located at the Company’s Scottsdale, Arizona R&D site. You will have close collaboration with R&D Engineering, Product Sustainment Engineering, Quality and Regulatory Affairs, Marketing, as well as other key functions to achieve business deliverables.  Your exceptional analytical, engineering, and organizational talent will lead to the execution of development projects within West.

 

Essential Duties and Responsibilities:

  • Product Development
  • Lead, implement and execute system engineering tools and processes within the R&D group.
  • Lead design control process of combination products throughout product life cycle in accordance with relevant standards and FDA guidance.
  • Participate in cross-functional teams for defining system design and performance requirements specifications while applying in-depth knowledge of design control of combination products.
  • Mentor and guide junior system engineers.
  • Provides a “Customer Service” attitude while interacting with both internal and external customers all whilst achieving work deadlines, production, and attaining quality standards.
  • Oversee risk management activities using tools such as FMEA and risk summary reports.
  • Oversee and document design inputs and linkage between the marketing requirements, standards review, risk management, user requirements and technical requirements.
  • Oversee and execute the documentation of design outputs and demonstrate traceability to design inputs with trace matrix (Product Requirement Matrix). 
  • Responsible for ensuring that all design control processes and documents adhere to West’s QMS.
  • Implement Systems Engineering best practices for methodology, attend Systems Engineering training, and conduct the necessary training for R&D staff as methodology is established.
  • Lead engineering and general design review as required.
  • Product Sustainment 
  • Collaborate with Sustaining Engineering, New Product Introduction, and Quality to facilitate change, and resolve new or existing product requirements issues. 
  • Maintain close alignment between yourself and direct Manager, that he/she is up to date with all work statuses, workload, problems that may arise, and progress as related to work assignments.
  • Ensure that development activities adhere to QMS, OSHA, local, state, and federal environmental regulations.
  • Improve processes and procedures to develop high quality products at a minimum cost.
  • Performs other related duties as assigned based on business needs.

 

 

Basic Qualifications: 

  • Minimum 5-8 years of experience in design control within the medical industry.
  • Bachelor's in Mechanical, Biomedical, Material Science, or related Engineering field.

 

Preferred Knowledge, Skills and Abilities:

  • Proven experience in risk management.
  • Background in R&D of Combination product/s.
  • Background in R&D of electromechanical medical device/s.
  • Knowledge of ISO-11608, IEC-60601, IEC-62304, ISO-14971 – advantage.
  • Excellent communication skills, both written and verbal.  
  • Admirable interpersonal skills.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target

 

Travel Requirements:

  • Must be able to travel up to 10-20% of the time

 

 

 

 

 

 

 

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.

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