Research and Development Engineer II at Compunnel Inc

Job Summary:

• 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 youll need (Required Qualifications):

• Bachelors 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
  Masters 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.