Position Overview:
We are seeking an experienced Manufacturing Engineer to join our team. The ideal candidate will have a strong background in SPC, Lean principles, GD&T, medical device manufacturing, and ISO 13485 standards.
The Manufacturing Engineer will be responsible for driving continuous improvement, maintaining quality standards, and ensuring efficient production processes. This role will require strong problem-solving skills, attention to detail, and the ability to work collaboratively with cross-functional teams.
Key Responsibilities:
Develop and implement quality control processes to ensure consistent and high-quality production of medical devices
Utilize SPC methods to monitor and analyze production data, identifying areas for improvement and implementing corrective actions
Utilize Lean principles to streamline production processes and eliminate waste
Interpret and apply GD&T principles to ensure proper design and functionality of medical devices
Ensure compliance with ISO13485 standards and other regulatory requirements
Lead root cause analysis (RCA) investigations and develop solutions to prevent reoccurrence of issues- Implement continuous improvement (CI) initiatives to optimize production efficiency and reduce costs- Conduct quality audits and implement corrective actions as necessary
Develop and execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols for new equipment and processes
Design and implement design of experiments (DOE) to optimize production processes
Utilize failure mode and effects analysis (FMEA) to identify and mitigate potential risks in production processes
Qualifications:
Bachelor's degree in Engineering or related field
Minimum of 3 years of experience in medical device manufacturing
Strong understanding of SPC methods and their application in production processes
Proficient in Lean principles and their application in process improvement
In-depth knowledge of GD&T principles and their application in design and manufacturing processes Thorough understanding of ISO13485 standards and other regulatory requirements
Experience conducting root cause analysis and implementing corrective actions
Proven track record of leading continuous improvement initiatives and achieving measurable results
Strong problem-solving and analytical skills
Excellent communication and interpersonal skills
Ability to work collaboratively with cross-functional teams
Experience with IQ/OQ/PQ protocols and DOE/FMEA methodologies is preferred.
Benefits
Vacation/PTO
Medical
Dental
Vision
401k
Applicants must be authorized to work in the U.S.
Kylie Mullins is recruiting for this position and the positions below.
Email me to apply for this position
Employees will receive paid leave to the extent required by state or local law
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.