Principal Engineer, R&D, Integrated Systems

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2.

Through our work to deliver thousands of life‑saving and life‑enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

• This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.
• Community Involvement:
  West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
• Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
• Continuous Learning & Development:
  Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill‑certification initiatives.

In this role you will lead design and development activities within West's Product Development Process demonstrating leadership and strategic thinking within a goal-oriented organization. The incumbent will demonstrate accountability for the successful and timely achievement of goals, work independently only with strategic guidance in the most complex situations, and interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/lead/develop solutions.

• Plan and execute projects through all phases with a focus on design and qualification through verification and validation.
• Create and edit Product models/drawings.
• Write engineering test protocols, reports, and work instructions.
• Lead technical reviews and design reviews.
• Apply engineering principles for design/analysis of complex technical problems.
• Drive innovation and process efficiency for Integrated Systems.
• Develop technical solutions to complex problems using sound engineering principles, utilizing experimental, computational, and analytical methods.
• Apply an innovative and logical risk‑based approach to product development challenges with the capacity for original thinking. Develop robust test methods, design test fixtures and execute measurement system analysis.
• Plan, execute, and analyze design of experiments (DOE).
• Write, implement and lead bench studies, tolerance stack‑up analysis, design verification, validation, materials specifications and component specifications.
• Generate, record and analyze data, present results to peers and business leadership.
• Integrate planning activities between West and development/manufacturing partners.
• Work closely with Procurement to identify and qualify vendors ensuring appropriate components are procured and delivered as needed throughout the phased development process.
• Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.
• Other duties as assigned.

• Bachelor's Degree in Mechanical or Biomedical Engineering required, or equivalent experience.
• Master's Degree in Mechanical or Biomedical Engineering preferred, or equivalent experience.

• Minimum 8 years in medical device design control and change management is required.
• Expertise with Risk Management, Design Verification & Validation strategy development and execution is required.
• Expertise with test method development, validation strategy, and execution is required.

• Proficiency in Solid Modeling/Drafting is required.
• Proficiency in solid mechanics/mechanics of materials is required.
• Proficiency in statistical methods/tools is required.
• Proficiency in project management is required.
• Able to comply with the company’s safety and quality policies at all times.
• Understand and follow guidelines for sensitivity with IP protection.
• Understand…