Principal Engineer, R&D, Integrated Systems

Requisition ID: 68678

Date: Feb 24, 2025

Location:

Exton, Pennsylvania, US

Department: R&D

Description:

This position is hybrid in Exton, PA. Candidates applying must be residing within a 50 miles radius to the job location.

Who We Are:

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?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

The R&D team within West’s Glass Systems business is seeking a Principal R&D Engineer. In this role you will lead

design & development activities within Wests Product Development Process demonstrating leadership and

strategic thinking within a goal-oriented organization. The incumbent will:

1. Demonstrate accountability for the successful and timely achievement of goals

2. Work independently only with strategic guidance in the most complex situations

3. Interpret internal and external business issues and unmet needs and take a broad perspective to

define/plan/lead/develop solutions.

Essential Duties and Responsibilities

• Plan and execute projects through all phases with a focus on design and qualification through verification

and validation

• Create, 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 of glass systems

• Develops technical solutions to complex problems using sound engineering principles, utilizing

experimental, computational, and analytical methods

• Applies innovative & logical risk-based approach to product development challenges with the capacity for

original thinking. Develops robust test methods, design test fixtures and execute measurement system

analysis

• Plans, executes, and analyzes design of experiments (DOE)

• Writes, implements and leads bench studies, tolerance stack up analysis, design verification, validation,

materials specifications and component specifications.

• Generates, records and analyzes data, presents results to peers and business leadership

• Integrates planning activities between West and development/manufacturing partners

• Works closely with Procurement to identify and qualify vendors ensuring appropriate components are

procured and delivered as needed throughout the phased development process

• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules

• Other duties as assigned

Education

• Bachelor's Degree in Mechanical or Biomedical Engineering required and

• Master's Degree In Mechanical or Biomedical Engineering preferred

Work Experience

• Minimum 8 years in medical device or Combination Product industry required and

• Experience in high-volume, automated manufacturing processes, and glass forming preferred

• Strong interpersonal and decision-making skills and the ability to effectively manage change anduncertainty

• Expertise 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

• Knowledge of applicable ISO, and USP standards for drug delivery

• Knowledge of applicable health authority regulations including FDA, MDR

• 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

Preferred Knowledge, Skills and Abilities

• Experience with Combination Products requirements and regulation is a plus

• Experience in high-volume, automated manufacturing processes, and glass forming is a plus

• Experience in Human Factors for Medical Devices is a plus

• Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies are a plus.

• Ability to lead and teach others to assess project/program needs, formulate strategies, build support, and execute initiatives

• Strong interpersonal and decision-making skills and the ability to effectively manage change and uncertainty

• Knowledge of applicable ISO, and USP standards for drug delivery is a plus

• Knowledge of applicable health authority regulations including FDA, MDR is a plus

Additional Requirements

• Understand and follow guidelines for sensitivity with IP protection

• Understand strategic direction and make contributions to strategy formation

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures. Concise presentation skills at high profile conferences if needed.

• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities

• Read and interpret data, information and documents

• Must maintain the ability to work well with others in a variety of situations and have reliable and predictable attendance

• Must be able to multi-task, work under time constraints and exercise timely decision making, problem solve, and prioritize

• Must be able to deal with ambiguity and have the ability to make independent and sound judgments

• Observe and interpret situations, analyze and solve problems

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Travel Requirements

20%: Up to 52 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.