Weiss-Aug MedPharma needs a Sr. Product Release Engineer to contribute to delivering high-quality, engineered solutions to customers worldwide, particularly in the medical device and life science industry, by designing, developing, testing, and evaluating products.
Requirements
- Minimum of a bachelor’s degree in mechanical engineering or biomedical engineering
- Minimum of 10 years of medical device or life science industry experience, preferably in a product development engineering position.
- Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products.
- Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact(s) on company objectives.
- Experience in Regulatory (FDA) requirements and processes for development.
- Knowledge of engineering principles and technology to develop new products, improve existing products, and ensure that design specifications are met.
- Familiarity with technologies such as progressive stamping, insert molding, factory automation and other related tooling/processes.
Responsibilities
- Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements.
- Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs.
- Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes.
- Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities.
- Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities.
- Understand and meet Regulatory (FDA) requirements and processes for development.
- Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s.
Other
- Minimum of a bachelor’s degree in mechanical engineering or biomedical engineering
- Minimum of 10 years of medical device or life science industry experience, preferably in a product development engineering position.
- Ability to work in a cross-functional team environment
- Excellent communication and interpersonal skills
- Ability to interface with customers on technical and schedule-related issues
