exton Work Opportunities ∙ Page 5

Job Summary

In this 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.

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. 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.

Education

• Bachelor's Degree in Mechanical or Biomedical Engineering or equivelant experience, required
• Master's Degree Mechanical or Biomedical Engineering or equivelant experience, preferred

Work Experience

• Minimum 5 years of experience in the medical device or combination products industry
• Expertise with test method development, validation strategy, and execution
• Expertise in medical device design control and change management
• Experience in high-volume, automated manufacturing processes, and glass forming
• Experience in Human Factors for Medical Devices
• Expertise with risk management, design verification & validation strategy development and execution
• Experience with combination products requirements and regulation

Preferred Knowledge, Skills and Abilities

• 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

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. 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 & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & 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, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Able to perform R&D lab activities
• Must be able to deal with ambiguity, use timely decision making, understand sensitivity for IP protection, deliver concise presentations to high-profile conferences, understand strategic direction, make contributions to strategy formation, be reliable and have predictable attendance

Travel Requirements

Physical Requirements