Summary / Objective:
The Product Bio-Science Engineer is responsible for supporting the entire product process for both new products and existing products from other established markets expanding to North America. The primary focus for this role is to work with the MIC NA Team from the initial design concept to design transfer and release to commercialization. The Product Bio-Science Engineer will actively participate in all phases of design, risk management reviews and testing to support design verification and validation activities.
ABOUT THE COMPANY:
Nipro Medical Corporation is a world leading manufacturer of Renal, Medical-Surgical and Interventional Radiology products. We are committed to delivering innovative, high quality and value- added solutions to improve patient care. Nipro Medical Corporation is a wholly owned subsidiary of Nipro Corporation, headquartered in Osaka, Japan. Established in 1954, our parent company employs more than 35,000 team members and is comprised of more than 250 operating companies in 56 countries. Our companies develop and market products in three business segments: Consumer, Medical Devices & Diagnostics and Pharmaceuticals. At least 1 billion people around the world are touched each day by what we do.
Education & Certification Requirements:
- Actively participate in all phases of product process including research, design, production and commercialization.
- Actively participate in the process of bringing new products to the North American market including support of documentation creation for successful 510(k) submission.
- Confirm that designs comply with applicable standard regulations and FDA guidelines.
- Assist in creation of product development, safety and performance testing protocols and technical reports.
- Work closely with the Product Development and Regulatory team to ensure that Technical Documentation conforms with appropriate standards, such as 21 CFR, FDA harmonized, ISO, IEC, (ISO 10993, IEC 62304, IEC 60601-2-16, and related standards) for 510k submissions.
- Ensure that the risk assessment with necessary and required testing for devices has been conducted.
- Actively participate in the risk management process ensuring consistent and detailed risk analysis documentation.
- Understand the nature of IEC safety, biocompatibility, human factors engineering, software reprocessing validation and preclinical research required by the FDA guidelines for the specific device.
- Coordinate and understand critical project activities to execute timely completion.
- Contribute to scheduled development milestones as well as project plan per product realization requirements.
- Examine and streamline existing processes in product development, to strengthen documentation creation and traceability.
Experience & Required Skills:
- Bachelor of Science degree in biomedical engineering or related engineering or bio-chemistry field.
- Minimum of (3) years of quality/regulatory and product process experience in medical devices.
- Ability to work within a team and as an individual contributor in a fast-paced environment.
- Strong verbal and written communication skills with ability to effectively interact at multiple levels within the organization.
- Must possess exceptional organizational skills, and attention to detail with the ability to remain focused and execute complex tasks.
- Proven track record for project prioritization, problem solving, sound decision making and timely project completion.
- Ability to travel approximately 20%.
- Strong background in quality and regulatory compliance.
- Requires a thorough knowledge of:
- The Food and Drug Administration’s Quality System Regulations CFR 21 Part 820
- Risk Management such as ISO 14971 Risk Management – Application of Risk Management to Medical Devices.
- Quality System Regulations such as ISO 13485
- Must be able to provide proof of eligibility to work in the United States at time of hire.
EEO Statement: Nipro Medical Corporation provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any time without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.