Project Manager - Medical Device Engineering
Phillips-Medisize Costa Mesa is seeking a dynamic and proactive functional Project Manager who will be focused on Medical Product Design and Engineering programs. This person will be working directly with medical device customers to turn projects into a comprehensive plan and drive towards quality and customer satisfaction.
Phillips Medisize is an end-to-end provider of Innovation, Development and Manufacturing Solutions serving Pharmaceutical, Diagnostics and Medical Device Customers. This Project Manager will play a critical role managing the client and electronic medical device project plans. This person will work with new product development engineering functions to collaborate and drive towards project succession.
This ideal candidate will have successful track record managing multiple projects from initial conception through product launch.
What you will do in your role.
- Engaging with customers to define initial project scope and working through pricing negotiations and contract completion.
- Working with cross functional groups to organize and influence project timelines.
- Developing a preliminary plan of investigation by analyzing customer input; determining project specifications such as: cost, time, and sample requirements.
- Tracking and reporting with a project manager tool and ensuring outward communication to teams, leadership and external partners.
- Creating and maintaining technical files including design history folders and project deliverables.
- Investigating new materials, processes, equipment to further broaden the company’s capabilities.
- Working with engineering capabilities to understanding tolerance analysis, engineering risks, DFMA, interpreting design prints
- Anticipating and mitigating risks throughout Project plans; proactively communication issues to clients and internal teams
- Work with the engineering team to ensure specification compliance in the areas of design, system performance, and delivery criteria
- Coordinate mold tool manufacturing, design and qualification teams
- Participate in design reviews internally and with external suppliers and customers
- Follow ISO 13485, FDA Medical Device Directives and other applicable standards
- Assist with troubleshooting and root cause investigations
- Provides direction for qualification protocols (test plans) such as design verification test plans
- 3+ years of relevant experience working with engineering teams
- 3+ years’ experience with project management
- Understanding of electrical cable assemblies
- Experience working with MS Project or related tools
- Bachelor’s Degree in Engineering or related technical field.
What will put you ahead?
- Medical Device experience
- Medical connector knowledge
- Experience using 3D modeling software.
- Design experience utilizing SolidWorks
- Familiar with the injection molding process
- Able to read work instructions and assembly/component level drawings
- Familiarity with ISO 13485, FDA Medical Device Directives and other applicable standards
- Six Sigma black/green belt
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