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Principle Engineer - Six Sigma

Requisition ID:  33405
Date:  Apr 9, 2021
Location: 

Scottsdale, Arizona, US

Department:  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:

As a Core Team Operations Representative (CTOR) your main objective will be to work within the product development teams throughout the product development process while ensuring operations needs and requirements are built into new products and any future product changes. This position will lead and support the creation and deployment of Design for Six Sigma (DFSS) processes utilizing DFSS tools and methodologies in the West organization. Reports directly to the Director, Industrialization Services.

 

Essential Duties and Responsibilities:

Core Teams Operations Representative:

  • Develop and Deploy Design for Sig Sigma (DFSS) in West. This will include training content, delivery of training, mentoring and coaching for all levels of the organization (New Employees, GBs, BBs, Management)
  • Utilizing DFSS tools and methodologies, ensure operations needs and requirements are built into new products and future product changes.
  • Coach and mentor individual candidates or teams of employees on proper DFSS method & tool selection and application on existing projects.
  • Lead the Operations/Engineering Playbook:
    • Drive the PDP activity: The Playbook itself, DFSS tools and methodologies and PDP metrics.
    • Ensure product development PDP metrics are tied to predictive metrics
    • Support selection of Production Technologies and Processes.
    • Support / lead other areas as requested.
  • Lead and/or attend Cross Functional Team (CFT) Product Design meetings and link new product activity between various global engineering groups as required.
  • Support Tolerance Analysis, pFMEAs and dFMEAs for new and existing products and recommend changes to designs if required to improve reliability of products.
  • Implement, interpret, correlate and communicate statistical studies performed on manufacturing processes / designs and review engineering experiments (DOEs) utilizing the results to make decisions affecting product direction.
  • Design for Cost – Lead COGs analysis with required functions.
  • Lead tasks within the PDP (Product Development Process); following West’s standards for Project Governance Management and Quality Systems requirements.
  • Provide updates in the operations Project Management Office as required/requested.
  • Provide product support to existing facilities production line for continuous improvement and best practice alignment.
  • Drive change within the West organization focusing on the manufacturability of new products
  • Performs other duties as assigned based on business needs.

 

Basic Qualifications:

  • Education or Equivalent Experience: Bachelor's in Engineering or Quality Field.
  • Must have a Design for Six Sigma Black Belt.
  • Must have experience in product development from concept to launch.
  • Must have experience deploying DFSS in a large multi-national organization.
  • Experience developing training materials.
  • Ability to evaluate and align DFSS practices with Quality Management System standards and requirements; defend actions and results under audit if required.
  • Training and application in applied statistics; ability to teach and explain practical use of statistical methods in a product development context (Taguchi, DOE, ANOVA, Sample Size Selection, Monte Carlo Simulations, MSA, etc.,).
  • Must have significant experience in DFSS tools and methodologies e.g. DFMA, DFR, Monte Carlo Simulation (Predictive Engineering tools), Triz, QFD, pFMEA, dFMEA, Tolerance Analysis, FTA, Critical Parameter Management, Universal Modelling Language (UML), DOE, Response Surface Methodology (RSM), Robust Design, Process Capability Analysis, Accelerated Life Testing (ALT)
  • Have a good knowledge of parts manufacturing processes (i.e. Injection moulding tool design, injection moulding (standard process and multi component) processing, ancillary equipment, robots and automation systems.
  • Familiarity with FDA requirements for a Corrective and Preventive Action Process.
  • Knowledge of US and international medical device quality system regulations and standards (21 CFR 820, ISO 13485).
  • Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
  • Must be able to work in a fast-paced environment.
  • Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
  • Must be able to deal with all levels of employees and work across various departments.
  • Must be able to work independently on own projects while working concurrently with all departments.
  • Experience: Minimum of 8 years of experience required in similar role.

Preferred Knowledge, Skills and Abilities:

  • Degree in Biomechanical / Mechanical Engineering. 
  • Preferably worked in either the medical, packaging or technological industries with a good understanding of the regulatory requirements and exposure to serialization.
  • Lean/Six Sigma Green or Blackbelt.
  • Design for Reliability & Manufacturing (DRM) Green or Black Belt.
  • Knowledge in computer systems; integrated manufacturing systems; word processing and spreadsheets.
  • 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
  • Able to comply with the company’s safety policy at all times.
  • Able to comply with the company’s quality policy at all times.

Travel Requirements:

  • Must be able to travel up to 30% of the time to domestic and international facilities.

 

 

 

 

 

 

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 kimberley.eby@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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