Job Description Position Overview: 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.
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
Job Number 9723BR
Career Field Engineering
Position Qualifications Required Qualifications:
Bachelor of Science with a minimum of 15 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
Skills and Abilities:
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.
About Phillips-Medisize, LLC... Phillips-Medisize, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.