Senior Manufacturing Engineer
Senior Manufacturing Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Senior Manufacturing Engineer will work with internal global operations and/or suppliers to ensure optimized processing is in place from raw material sourcing through final packaging validation. The position will also focus on commercialized product maintenance and lead continuous process improvement and leadtime reduction activities ensuring proper change control is followed.
Essential Duties & Responsibilities:
- Achieve business objectives: support quality speed to market planning & control of manufacturing cost process risk management cycle time reduction and new supplier validations.
- Achieve business objectives: support quality speed to market planning & control of manufacturing cost process risk management cycle time reduction and new supplier validations.
- Interface with key business partners and represent manufacturing on new product introduction teams.
- Complete verification and validation master plans for supplier qualification and / or certification. Lead validating specialized processes (cleaning sterilization biocompatibility porous and plasma coating additive manufacturing etc..
- Orthopedic manufacturing process development (Master routes BOMs defining inspection criteria cleaning packaging labeling) and supplier control plans.
- Support and sustain harmonized US packaging and labeling systems and processes: design layout approval release and printing.
- Responsible for sustaining manufacturing BOMs item cards routings engineering change review NCEs CAPAs and process specifications.
Minimum Requirements:
- Bachelors degree in engineering field or related discipline.
- 2 plus years of experience of manufacturing cleaning inspection packaging and labeling processes.
Preferred Qualifications:
- Knowledge of Product Lifecycle Management Unique Device Identification Direct Part Marking.
- Knowledge ofadditive and/or subtractive manufacturing processes.
- Knowledge and experience working with ISOand 21CFR Part 820 regulations.
- Demonstrated use of quality tools (Statistics Lean Six Sigma DOE etc.
- Analyze and interpret engineering drawing specifications per ANSI 14.5 and established drafting standards.
- Project Management skills.
- CNC knowledge
Required Experience:
Senior IC
Employment Type
Full-Time
