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Product Development Lead

Description

Phillips-Medisize, a Molex Company, is seeking a Product Development Lead to use their deep understanding of Product Development processes for Combination Products, Quality and Regulatory standards, along with personal experience, to provide technical guidance and leadership to a cross functional product development team at our Global Innovation and Development center (GID) in Hudson, WI.

What You Will Do In Your Role:

  • Act as the project team technical expert in the development of combination products according to the Phillips-Medisize Design Development Process and relevant regulatory standards
  • Provide technical guidance and leadership to a wide range of disciplines including Industrial Design, Human Factors, Mechanical, Electronic, Software, Systems and Test Engineering 
  • Understand customers program goals, including their clinical and regulatory strategy and work closely with the customer, Phillips-Medisize Program management and technical team to define or modify scope of work and activities to realize mutual success
  • Support the Business Development and Cost Estimation teams in initial customer meetings, scope development and proposal development

The Experience You Will Bring:

Basic Qualifications:

  • 10+ years of experience in the development of drug / biologic delivery devices such as pen injectors, auto-injectors, wearable bolus injectors, dry powder inhalers or metered dose inhalers

Education: 

  • Bachelor of Science in engineering or related disciplines

Preferred Qualifications:

  • Experience in the development of User and Stakeholder Needs and Design Input Requirements
  • Experience in the understanding of various regulatory submission approaches and their impact on the Product Development Process
  • Demonstrated experience over a wide range of different products and product types
  • Demonstrated ability to apply a risk based decision making process to help customers and/or teammates understand and rationalize various approaches to problem solving
  • Ability to technical review of either mechanical design, electronic design or embedded firmware
  • Competent in ISO 13485 Design Controls, ISO 14971, and IEC 62366
  • Proficient in the use of prioritization and decision-making tools/techniques
  • Strong analytical ability to guide complex design teams
  • Leadership skills including ability to lead, mentor, and maintain confidentiality
  • Strong organizational, written, verbal and interpersonal communication skills
  • Bilingual skills a plus
  • Fluent in Microsoft Office programs including Visio, Excel, Word and Power Point
 

This position does not qualify for VISA sponsorship

In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.

Salary and benefits commensurate with experience.  

Equal Opportunity Employer.

Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.

This employer uses E-Verify. Please visit the following website for additional information:

www.kochcareers.com/doc/Everify.pdf

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