Principal Engineer, Research and Development, Integrated Systems job at West Pharmaceutical Services in Exton, PA
Title: Principal Engineer, R&D, Integrated Systems
Job Description:
Requisition ID: 72853
Location: Exton, PA, US
Department: R&D
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?
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.
What We Offer
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.
Job Summary
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.
Essential Duties and Responsibilities
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
Develops technical solutions to complex problems using sound engineering principles, utilizing experimental, computational, and analytical methods
Applies innovative and 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, or equivalent experience
Master's Degree In Mechanical or Biomedical Engineering preferred, or equivalent experience
Work 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
Additional Requirements
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 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 #LI-JJ1 #LI-HYBRID
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
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 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.
Apply Now
Apply Now
Job Description:
Requisition ID: 72853
Location: Exton, PA, US
Department: R&D
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?
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.
What We Offer
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.
Job Summary
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.
Essential Duties and Responsibilities
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
Develops technical solutions to complex problems using sound engineering principles, utilizing experimental, computational, and analytical methods
Applies innovative and 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, or equivalent experience
Master's Degree In Mechanical or Biomedical Engineering preferred, or equivalent experience
Work 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
Additional Requirements
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 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 #LI-JJ1 #LI-HYBRID
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
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 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.
Apply Now
Apply Now