Product Development Lead - Combination Devices
This Product Development Lead can work remote anywhere in the United States.
Phillips-Medisize is a leading global outsource provider of design and manufacturing services to the medical (medical device, diagnostics, and drug delivery products) and specialty commercial markets.
Our Global Innovation and Design Center is looking for a Product Development Lead to use their deep understanding of Product Development processes for Combination Products, Quality and Regulatory standards to provide technical guidance and leadership to a cross functional product development team. The Product Development Lead will make meaningful contributions throughout our Design Development Process with an emphasis on medical device product development.
What You Will Do In Your Role
- Contribute during all phases of the product development cycle and act as the project team technical expert in the development of combination products
- Design in accordance to the Phillips-Medisize Design Development Process and relevant regulatory standards
- Develop User and Stakeholder needs and design input requirements and consider various regulatory submission approaches and their impact on the Product Development Process
- 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, program management and technical teams
- Contribute to project definition and 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
- Develop close working relationships with new and existing customers
- Apply a risk based decision making process to help customers and/or teammates understand and rationalize various approaches to problem solving
- Leverage prioritization and decision-making tools and techniques
The Experience You Will Bring
- Bachelors degree in Engineering
- Expertise in the development of drug / biologic delivery devices such as injectors and inhalers
- Experience with ISO 13485 Design Controls and/or ISO 14971
- Requires applicants to either provide proof of U.S. citizenship, Green Card or be eligible to receive an export authorization (ITAR)
What Will Put You Ahead
- Experience directly managing a team
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