- 7+ years of experience or equivalent experience in Medical Device manufacturing and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC60601.
- Bachelor's degree in engineering or life science discipline
- Experience with manufacturing transfer, process validation and sustaining of mechanical and software driven devices.
- Experience with process risk management creation and maintenance.
- Experience with test method development and the validation of those test methods.
- Experience with the development and implementation of inspection plans.
- Strong technical ability using computational tools and electronic QMS.
- Ability to quickly learn new applications, tools, and concepts.
- strong work ethic and an ability to excel in a flexible and fast-paced work environment.
- Ability to provide guidance and mentorship of good quality principles and practices.
- Excellent written/oral communication skills required.
- Master's degree in engineering or life science discipline
- Must be able to work effectively with diverse groups of people.
- Six Sigma (DMAIC)
- Lean
- Metrology, process mapping, pFMEA, control planning, test method validation, validation, process improvements, CAPA, NC, and change management.
- Ability to review and approve changes to currently commercialized product regarding the process risk management of the product.
- Applies statistics to make business decisions.
- Ability to conduct failure investigation and root cause analysis.
- Must be able to work in lower maturity processes using critical thought to provide pathways for business continuity and improve the systems.
- Coordinate and work closely with other engineering, logistics, financial, and program management disciplines to define system specifications and requirements.
- Attends and participates in departmental meetings.
- Attends seminars and training sessions necessary to maintain.
- appropriate level of professional competence.
- Ensures all department compliance guidelines are met.
- Attends all meetings, in-services training, or continuing education as delegated by the supervisor.
- Provides customer focused interactions.
- Performs all duties necessary for the department as per department policies and procedures.
- Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.
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Description
As a Senior Manufacturing Quality Engineer, you are responsible for identifying and supporting continuous improvement as it relates to manufacturing transfer and daily production. The ideal candidate will be an adequate problem-solver who is confident implementing appropriate changes and should be comfortable working closely with multiple departments.
QUALIFICATIONS
PREFERRED EDUCATION/SKILLS
DUTIES AND ESSENTIAL FUNCTIONS
Each employee consistently demonstrates the following essential functions:
