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
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.
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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
Preferred Knowledge, Skills and Abilities
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
30%: Up to 78 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.
Additional Requirements
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
Proficiency in Solid Modeling/Drafting
Proficiency in solid mechanics/mechanics of materials
Proficiency in statistical methods/tools
Proficiency in project management
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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