Job Summary
The Principal Engineer performs disposables engineering and technical project management responsibilities for the development, commercialization, and life-cycle management of single-use disposables kits for BU-TCT apheresis collection systems and related disposable products.
Apply specialized knowledge to manage and complete complex projects, including design or process related activities. Develop strategies where clear guidelines do not exist and creative thinking is required. Generate and implement innovative solutions to highly complex problems.
Lead activities to meet business goals by driving quality improvements, meeting delivery requirements and implementing cost reductions and product enhancements. Requires working in a team environment with cross functional team members, such as manufacturing sites, marketing, quality, regulatory and other departments.
Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.
Responsibilities
- Displays standard engineering principles to resolve difficult problems, from conception to final design with team input.
- Plans, schedules and leads project assignments in the evaluation, selection and adaptation of various engineering techniques, procedures and criteria with very minimal to no guidance.
- With very minimal to no guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger complex project; includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups.
- Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
- Supervises/coordinates an engineer and/or technicians on assigned work.
- Advise and convince management on proposals and courses of action using both written and verbal methods.
- Effectively operate in and facilitate cross-functional teams with minimal guidance.
- Provides solutions and recommendations that reflect understanding business objectives and cost implications.
Requirements
B.S. degree in Engineering (materials, biomedical, industrial, or mechanical) with 5-7 years of specialized experience in the medical disposables/device products field or advance technical degree.
Experience in compliant practices of design control and medical device risk management.
Excellent verbal and written communication skills.
Strong leadership and project management skills.
Strong analytical capability and attention to detail.
Ability to operate independently and exercise good judgment.
Preferred experience with systems design and system integration for complex medical devices
Experience in an FDA regulated industry, especially with medical device products.
A solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
Project management skills with the ability to prioritize multiply tasks.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
