- This section contains a list of essential functions of the position.
- Please list in priority order.
- The incumbent will perform other duties assigned.
- This individual will be expected to independently lead or support disposable development initiatives based on an established project plan.
- This individual will work with cross-functional team to develop and execute development activities. Conduct process qualifications, including IQ, OQ, and PQ of process operations, including production equipment.
- Author development or qualification protocols and final reports.
- Perform standard design and engineering tasks, trouble shoot problems, and execute protocol testing to support experimental or functional evaluation studies.
- Plans, schedules and conducts project activities in the evaluation, selection and adaptation of various engineering techniques, procedures, and criteria.
- Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
- Apply advanced techniques and procedures to assigned projects.
- Proficient use of test equipment used for investigation and qualifications, including Instron, balance, microscope, measurement devices (calipers, micrometer, and optical comparator).
- Responsible for the experimental design, fixturing, prototype development and functional analysis for various process or development activities.
B.S. degree in Engineering (systems, biomedical, mechanical, or similar engineering discipline) with 2 to 3 years of experience in disposable development and experience desired. Preferred skills include problem solving, CAD design capability, joining technologies, such as R.F. Sealing, Ultrasonic welding, and solvent bonding techniques as used in disposable sets. Manufacturing experience preferred. Computer skills should include MS Word, MS Excel, MS Powerpoint, MS Project, and Mini-Tab. Six sigma training also preferred. Excellent written and verbal communication skills. Prefer knowledge with FDA regulation, especially with medical drug and device products. Proficient in writing, including Protocols, Design Requirements, Design / Change Control documents. Strong problem solving and analytical skills.
Job Type: Full-time
Salary: $50,000.00 /year
- Disposable development: 3 years (Required)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off