Sr. Engineer, R&D

West Pharmaceutical Services•Uwchlan Township, PA

22h•Hybrid

About The Position

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 SummaryIn this hybrid role, you will support 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, interpret internal and external business issues and unmet needs, and take a broad perspective to define/plan/lead/develop solutions. You may collaborate with local and global functional groups, stakeholders, and management to deliver project goals and meet project milestones.

Requirements

Bachelor's Degree in Mechanical, Chemical or Biomedical Engineering required; or equivelant experience required
Minimum 5 years Experience in regulated industry required or 5 years medical device or combination product industry highly preferred
Experience in high-volume, automated manufacturing processes, and glass forming preferred
Experience in Human Factors for Medical Devices preferred
Expertise with test method development, validation strategy, and execution preferred

Nice To Haves

Master's Degree Mechanical or Biomedical Engineering preferred; or equivelant experience preferred
Expertise with risk management, design verification and validation strategy development and execution
Expertise in medical device design control and change management
Experience with combination products requirements and regulation
Proficiency in solid modeling/drafting
Proficiency in solid mechanics/mechanics of materials
Proficiency in statistical methods/tools
Proficiency in project management
Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies
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
Knowledge of applicable health authority regulations including FDA, MDR
Ability to comply with the company's safety and quality policies at all times

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.
Plan, execute, and analyze design of experiments (DOE).
Lead technical and design reviews.
Drive innovation and process efficiency of integrated systems by applying innovative and logical risk-based approach to product development challenges with the capacity for original thinking.
Apply engineering principles for design/analysis of complex technical problems and develop solutions using sound principles, and utilizing experimental, computational, and analytical methods.
Examine solutions based on functionality, quality and cost.
Write, implement, and leads bench studies, tolerance stack up analysis, design verification, validation, materials specifications, and component specifications.
Generate, record and analyze data, and present results to peers and business leadership.
Point of contact for technical product related discussions with the team. May provide technical expertise and communication for internal and external partners.
Integrate planning activities between West and development/manufacturing partners, and work closely with Procurement to identify and qualify vendors ensuring appropriate components are procured and delivered as needed throughout the phased development process.
May characterize system and/or sub-system inputs, outputs and functionality, utilize analytical skills and develop simulation tools to define appropriate product specifications, and system reliability.
May implement best practices for methodology, and attend and conduct necessary training for staff as methodology is established. Mentor and guide system engineers.