Research and Development Engineer II
2 days ago
- This Engineer II will
apply knowledge of quality engineering principles and methods to ensure
compliance with regulatory requirements and systems/procedures to optimize
product design, internal and external device manufacturing, and device
distribution. Furthermore, this Quality Engineer will coordinate and
perform complaint investigations as well as DMR/DHR changes in support of
clinical inventory.
How you will make an impact:
- Support areas of Quality
Assurance, Design Controls, Risk Management, Manufacturing Controls, and
Statistical Techniques for New Product Development (NPD) programs - Investigate complex
manufacturing product quality and compliance issues reported from the
field, analyze results, determine root cause/probable cause, and initiate
and review reports. - Coordinate and execute
change control activities to support rapid innovation - Support design and
development activities (i.e., engineering study, feasibility testing,
drawing review, etc.) - Participate in
escalation tasks and activities, including Project Risk Assessments (PRA) - Supports or leads test
method development/validation activities for Design Verification testing
and manufacturing inspections for NPD programs - Collaborate with R&D
and Manufacturing organizations to facilitate the successful execution of
the NPD process and launching of robust products - Develop complex
experiments and tests (including writing and executing protocols) to
create, improve, and validate products and manufacturing processes by
analyzing results, making recommendations, and developing reports - Develop, update, and
maintain technical content of risk management files - Develop training and
documentation materials (e.g., work instructions) for production to enable
the seamless knowledge transfer of project and manufacturing processes - Assign and oversee
manufacturing support tasks; give instruction to technicians on conducting
tests; train technicians and provide feedback; and coordinate technician
work - Other incidental duties
assigned by Leadership - Ability to travel up to
10% domestically and internationally
What you'll need (Required Qualifications):
- Bachelor's degree in
Engineering or Scientific field with a minimum of (2) years of experience
in either NPD, Quality Engineering, R&D, and/or Manufacturing; OR a
Master's degree in Engineering or Scientific field with internship, senior
projects, or thesis experience required. - Engineering experience
within a highly regulated industry
What else we look for (Preferred Qualifications):
- Experience in medical
devices (cardiovascular, endovascular, or other critical care/surgical
products), healthcare, or a related environment preferred. - Knowledge and experience
within Design Assurance, including Design Controls, Design Verification
& Validation, Test Method Development, and Process Validation - Experience with root
cause analysis or investigations for Complaints, NCRs, and/or CAPAs. - New Product Development
experience from initial concept to commercialization (Class III
preferred). - Experience with Risk
Management and Design Control - Proven expertise in
usage of MS Office Suite including MS Project - Basic understanding of
statistical techniques - Strong problem-solving,
organizational, analytical, and critical thinking skills
Education/Experience:
- Bachelor's degree in
engineering required. - 2-4 years experience
required.
Education: Bachelors Degree
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