Principal Biomedical Engineer

PRINCIPAL DEVICE ENGINEER
ROLE SUMMARY
The Sr. Biomedical Engineer is responsible for developing design concepts for new products, as well as sustaining engineering and enhancements of marketed products. Designs, develops, and/or fabricates test fixtures/test items. Writes SOPs, test protocols and laboratory research reports. Documents laboratory testing protocols and results as per corporate policies. Performs market research, user studies and supports clinical studies. Responsible for documenting development work per design control requirements in Design History Files.
ROLE RESPONSIBILITIES
Conceptual design of new drug delivery systems or product enhancements. Develop prototypes for new product concepts. Draft, review and approve; engineering and design control documents, such as product requirements, detail drawings, assembly drawings, tolerance stack analyses, change orders, risk management documents, design verification and validation plans, protocols, and reports. Engineering study test methods, test plans, protocols, and reports. Perform engineering study testing. Develop product simulators for market research and user studies. Design test fixtures or components. Provide cross-functional leadership. Work with tooling engineers and suppliers to develop and qualify component manufacturing processes. Work with product assembly, drug compounding and filling engineers and suppliers to develop and qualify manufacturing processes. Comply with FDA Regulations and Guidance for Combination Products.
BASIC QUALIFICATIONS
M.S. Degree or higher in Engineering discipline with 5+ years' experience
B.S. Degree in Engineering discipline with 10+ years’ experience
(Biomedical Engineering or Mechanical Engineering preferred)
PREFERRED QUALIFICATION:

• Conceptual design skills
• Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
• Strong mathematical, analytical, and reasoning skills
• Problem solving skills.
• Good research skills
• Good organizational skills
• Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
• Strong in teamwork
• Strong oral communication
• Strong written communication
• GD&T
• Rapid prototype modeling including use and maintenance of 3-D printers.
• Experience complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives

Kindeva Drug Delivery (KDD)/Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. KDD/MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
KDD/MMT requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, MMT will consider requests for Reasonable Accommodations.