Sr. Quality, New Product Development Engineer
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POST DATE 8/19/2016
END DATE 12/19/2016
JOB DESCRIPTIONEXCELLENT OPPORTUNITY WITH GLOBAL FORTUNE 300 MEDICAL DEVICE ORGANIZATION!
SR. QUALITY, NEW PRODUCT DEVELOPMENT ENGINEER
LOCATED IN KALAMAZOO, MI
GREAT CAREER ADVANCEMENT OPPORTUNITIES
RELOCATION ASSISTANCE AVAILABLE
SUMMARY OF POSITION
Advanced QualityEngineers are an integral and vital part of our research and development teams. With a focus on new product development, they interface with numerous functions of the business, including marketing, R&D, clinical, regulatory, and operations. Their primary goal is to ensure that the products we design and manufacture all over the world continue to meet and exceed customer needs. Whether helping turn voice of customer into user needs, evaluating risk of new products, creating inspection criteria, or performing validation in simulated use cases with our surgeon, nurse, technician, and specialist customers, Advanced QualityEngineers are focused on building quality into the products that we sell.
For this position, our client is looking for an experienced electro-mechanical engineer having a solid track record of class 2 and/or class 3 medical device commercialization. The successful candidate will have the opportunity to work with some of the top technical professionals in the medical device industry bringing cutting-edge technologies to market. Specifically, this role is within our surgical robotics group, which is focused on generating revolutionary technologies that we believe will change the way medicine is practiced.
Successful incumbents are passionate coaches and cooperative partners with their colleagues in research, development, operations and other departments that are both internal and external to our client. Key responsibilities for this role include:
* Ensure adherence to and guide continuous improvement of the established development processes, practices and methods.
* Ensure that software, mechanical, electronic, and material/implant engineering follow the same approaches, wherever possible, to ensure seamless cooperation between these diverse disciplines and their associated system responsibilities.
* Develop quality assurance plans for new product development programs.
* Provide expertise in establishing good specifications and protocols like requirements, architecture, detailed design, verification & validation planning, etc.
* Help facilitate world class risk methodologies for complex systems based upon existing corporate approaches. Practically apply advanced quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
* Conduct, moderate, and participate in design reviews.
* Establish system / subsystem test design in cooperation with test engineering.
* Educate the organization in exceptional engineering processes including good documentation, formal design reviews, and the other best practices.
* Coordinate activities with counterparts in other functional areas, both inside and outside the division, to ensure product quality and timeliness of release.
* Lead and facilitate the creation of necessary documentation to comply with regulatory requirements and internal policies, practices and procedures.
* Interface with customers in actual and simulated surgical environments to establish user needs and validate final device design.
* Work with suppliers to develop robust quality practices.
* Facilitate the PPAP process for new parts.
* Direct, mentor and assess the performance of junior level softwarequalityengineers.
* Assess and report project execution status to senior level management.
EDUCATION & QUALIFICATIONS:
* BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Computer Engineering, or related Engineering degree. M.S. and professional Masters degrees in relevant engineering disciplines are highly preferred.
* Minimum 2 years of experience in qualityengineering in a regulated environment. Strong preference given to candidates with experience in new product development, focused on qualityengineering related activities. Strong preference given to candidates with 4+ years of experience and with experience specific to the medical device industry.
* Working knowledge of risk analysis methodologies, GD&T, PPAP, SPC, Root Cause Analysis, and Statistics.
* Working knowledge of FDA QSRs, ISO 13485 and ISO 14971 standards.
* Proficiency with Mini-tab or similar statistical analysis program.
* Certified QualityEngineer (CQE) or other relevant ASQ certification preferred.
* Six Sigma and/or Lean certifications preferred.
* Class II/III medical device experience preferred.