Job Description
Overview:
We are seeking an Advanced Manufacturing Engineer to join our client's team in supporting the development and validation of new production lines for Ligasure Exact, a cutting-edge medical device. The ideal candidate will possess expertise in Process Validation, Design of Experiments, and Gauge R&R. This role will collaborate closely with a lead Manufacturing Engineer to ensure the successful implementation of new manufacturing processes.
Key Responsibilities:
- Assist in the development and validation of new production processes for Ligasure Exact.
- Define and characterize the manufacturing process window, ensuring process capability across all variations in production materials and processes.
- Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
- Generate required documentation to support manufacturing protocols, reports, changes, and instructions, including Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders, and statistical analysis.
- Provide engineering support to manufacturing operations and address quality issues arising on the production floor.
Minimum Requirements:
- Bachelor’s Degree in a technical discipline.
- Minimum 4 years of experience in Manufacturing Engineering.
Must-Have Technical Skills:
- Process Validation
- Design of Experiments
- Gauge R&R
Nice-to-Have:
- Master’s Degree in a technical discipline.
- Medical Device and/or Manufacturing Experience.
- Experience with materials joining processes, such as laser welding, ultrasonic welding, or resistance welding.
- Laser marking experience.
- Experience developing vision inspection/verification systems.
Work Schedule:
- 40 hours per week
- Fully onsite
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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