The Project Engineer will lead a cross functional team through design and manufacturing development projects while effectively managing budget, scope, schedule and risk; facilitate communication between the customer, different functional areas and Phillips-Medisize production facilities; manage / strengthen relationships with the customer.
What You Will Do in Your Role
- Lead a cross functional team of technical disciplines through the design development process from project kickoff into production transfer
- Learn and understand the Design Development Process and tools and the interdependencies of the different functional areas
- Coordinate, direct and lead engineering efforts to ensure optimum engineering of projects/programs to meet customer and manufacturing requirements
- Create, monitor, maintain, and communicate the project scope, schedule, cost, and risks, ensuring that the entire team understands their role in the project success
- Manage clinical builds from early concept development through the clinical build process.
- Create, review, and approve manufacturing documents and changes via the ER process and route for customer approvals
- On smaller projects, provide project management / technical direction to internal /external team members
- Be the single point of contact for the customer when working on capturing replacement, or expanded scope business.
- Work with the Business Development Team, Customer and Cost Estimating to generate new or updated proposals
- Manage multiple projects simultaneously
- Lead and/or co-facilitate a team through root cause analysis efforts
- Implement technical solutions to meet customer and Phillips-Medisize cost, quality, and delivery expectations
- Be the single point of contact for the customer when working on capturing repeat, replacement, or expanded scope business. Work with the Business Development Team, Customer and Cost Estimating to generate new or updated proposals
- Provide strong project management direction to development teams
- Facilitate project set-up and resource management by requesting resources from respective area managers, for specific scopes of work, and monitor team resources during project execution
- Maintain cost control and profitability through interaction with the accounting group, sales, and our customers. Work with appropriate financial personnel to generate financial status reports for communication and approval by the customer
- Manage the technical procurement needs of internal and external services/resources such as; contract personnel, purchased components, equipment and prototypes, etc.
- Support product compliance by working with Quality
- Adhere to facility and corporate quality systems, SOP’s & WI’s
- Know and understand personal role in compliance to ISO 13485 w/ design controls, and ITAR as required
- Review and approve appropriate drawings, specifications, and documents through the ER process
- Facilitate appropriate multi-disciplinary involvement in the creation of characterization or verification tests
- Generate and control planning documents according to relevant work instructions
The Experience You Will Bring
- Minimum 5 years of medical device, medical manufacturing, pharmaceutical, or closely related industry experience
- Experience in ISO 13485 design or clinical build experience
- Experience quoting design, tools / equipment and parts
- Experience working with SAP in a Design Development organization
- BS degree in an Engineering discipline
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