Title:  Manager ,Product Engineering,R&D

Job Summary

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.
• 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

Additional Responsibilities

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

License and Certifications

Travel Requirements

Physical Requirements

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

What We Offer

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