Job Description

Works independently and/or cross-functionally to support production operations and process development activities on new and existing products; ensures efficient and effective transfer of product into production for long term sustainability.

DUTIES & RESPONSIBILITIES:

• Assesses process capabilities and innovate and implement process improvements in production.
• Conducts process validation activities including IQ, OQ and PQ for equipment and processes and software validations.
• Applies technical knowledge and statistical tools to develop, characterize, and optimize processes.
• Able to design and develop tooling fixtures and semi automated systems to aid in process manufacturability.
• Trains and/or provides work direction to technicians and production operators when required as part of validation activities and process improvements.
• Executes the functional deliverables associated with Product development and Quality Systems.
• Supports new product development activities and product manufacturing transfer into production
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOMs, DMRs, Routers, Manufacturing Instructions, FMEAs, etc.); Generates documentation changes/justification through ECO process.
• Plans, organizes, and conducts all aspects of technical reviews.
• Writes and reviews validation protocols and reports applicable to new process improvements.
• Oversees engineering builds using special work requests.
• Leads or assists in developing and implementing preventive and corrective action plans.
• Drives Design for Manufacturability (DFM) effort with product development team.
• Provides production support to ensure Production Goals and Schedules are achieved.
• Minimizes waste in the production process.

PREFERRED QUALIFICATIONS:

• Must be creative problem solver
• Proven results in reducing cycle time and improving labor efficiency
• Must have strong verbal and written communication skills
• Ability to work in a fast paced environment where priorities are dynamic; must have well developed task/activity prioritization optimization skills
• History of success in being able to conceptualize, design, assemble and debug tooling and fixtures; optimize existing and new manufacturing processes.
• Able to use CAD system, Solidworks preferred
• Strong documentation skills, familiar with EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive), and FDA QSR regulations.
• Understanding of GMP requirements
• Experience with production tools such as ECO process and demand flow preferred
• An understanding of statistical software.
• Must have hands-on experience in process validation activities including IQ, OQ, PQ and tooling qualifications. 
• Ability to lift a minimum of 40 pounds.

Preferred Education and/or Job experience:

• BS in Engineering/Technical field; 7+ years Medical Device experience preferred.
• Experience with medical device disposable products and capital equipment

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