Reference #: 1059128401
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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 and development activities within Wests 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.
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 of glass systems
Develop technical solutions to complex problems using sound engineering principles, utilizing experimental, computational, and analytical methods
Apply 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, and presents results to peers and business leadership
Integrates 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
Other duties as assigned
Education:
Bachelor's degree in Mechanical or Biomedical Engineering or equivalent experience
Work Experience:
Minimum 8 years of experience in medical device or Combination Product industry
Expertise in medical device design control and change management
Expertise with Risk Management, Design Verification & Validation strategy development and execution
Expertise with test method development, validation strategy, and execution
Knowledge of applicable ISO, and USP standards for drug delivery
Knowledge of applicable health authority regulations including FDA, MDR
Proficiency in Solid Modeling/Drafting
Proficiency in solid mechanics/mechanics of materials
Proficiency in statistical methods/tools
Proficiency in project management
Preferred Knowledge, Skills and Abilities:
Master of Science degree
Experience with Combination Products requirements and regulation
Experience in high-volume, automated manufacturing processes, and glass forming
Experience in Human Factors for Medical Devices
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
Able to comply with the company's safety and quality policies at all times
Travel Requirements:
Must be able to travel up to 30% of the time
Physical Requirements:
Job demand classification is Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
Additional Requirements:
Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment and/or R&D lab. 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 strategic direction, adhere to procedures and make contributions to strategy formation
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
Must be able to multi-task, work under time constraints, problem solve, prioritize and make timely decisions
Ability to deal with ambiguity and make independent and sound judgments
Observe and interpret situations, analyze and solve problems
Reliable and predictable attendance
Sensitivity for IP protection
Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety and quality rules
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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 . 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.
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 disability or special need that requires accommodation, please send an email to peggy.tayloe@westpharma.com.
