Results matter. To everyone.
Sr. Manufacturing Engineer
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.
- 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