7+ years in Medical Device manufacturing with ISO14971, 21CFR820, ISO13485, IEC62304, IEC60601 expertise.
Bachelor's degree in engineering or life sciences.
Experience in manufacturing transfer, process validation, and sustaining mechanical/software devices.
Proficient in process risk management and maintenance.
Skilled in test method development and validation.
Experienced in creating and implementing inspection plans.
Strong technical skills with computational tools and electronic QMS.
Responsibilities
Lead metrology, process mapping, pFMEA, and control planning efforts.
Review and approve changes to commercialized products regarding process risk management.
Apply statistical methods for informed business decisions.
Conduct failure investigations and root cause analyses.
Work in lower maturity processes to enhance business continuity and systems.
Collaborate with engineering, logistics, financial, and program management teams to define specifications.
Ensure compliance with departmental guidelines.
Benefits
Full-time position with onsite work in Bothell, WA.
Opportunity for professional development through seminars and training sessions.
Engagement in a collaborative environment with diverse teams.
Mentorship opportunities to guide quality principles and practices.
Full Job Description
POSITION: Senior, Manufacturing Quality Engineer
FULL-TIME/PART-TIME: Full Time
LOCATION: Bothell, WA
GENERAL SUMMARY This role, the Senior Manufacturing Quality Engineer leads process risk management for manufacturing transfer and daily production demand and identifies and supports continuous improvement opportunities.
QUALIFICATIONS
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.
Preferred Education
Master's degree in engineering or life science discipline
Preferred Experience
Excellent written/oral communication skills required.
Must be able to work effectively with diverse groups of people
Six Sigma (DMAIC)
Lean
Physical Demands
Requires normal visual acuity and hearing.
Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.
Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
Additional skills may be required to perform additional task(s) specific to work location, department or line of business.
Working Conditions
Predominantly operates in an office and manufacturing environment
Onsite (not hybrid or remote)
DUTIES AND ESSENTIAL FUNCTIONS Each Employee consistently demonstrates the following essential functions:
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 w.r.t. 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.
