The Senior Process Engineer will be responsible for assuming the role of technical & business lead on new product and process introductions. Will be responsible to ensure complete Production facility preparation of the new product & process. Ensures that all technical and business-related demands such as building, facilities, utilities, machine & equipment capacity, hiring, procedure writing, training, verifying & validating, protocol & report writing, problem solving, demand planning and performance metrics are successfully executed and achieved. Serve as the voice of operations between the development site and manufacturing site during the new product/process development process
- Prepare the manufacturing facility, and coordinate the transfer, for the full-scale implementation of new products/processes to the production floor.
- Provides on-going status reports and observations to management and key stakeholders.
- Reports problems clearly and concisely, recognizing and highlighting specific deviation.
- Operate within Stryker’s quality system to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans, material & equipment specifications, user requirement specifications, and standard operating procedures/work instructions.
- Conduct process validations and process risk analysis for new product introductions.
- Evaluate “out of specification” results and associated corrective actions within the validation effort.
- Commitment to quality by striving for reliability and quality, continuously searching for ways to enhance performance and meeting all training and documentation criteria.
- Responsible for monitoring and reporting to pre-established KPI metric on the newly implemented product transfer for a period of 3-6 months.
- Must ensure achievement of KPI’s before responsibility is transitioned to Manufacturing Engineering for 3+ years of quality or validation engineering experience in the medical device, or equivalent, industry experience.
- A minimum of a bachelor’s degree in Chemical Engineering, Materials Science, Mechanical Engineering, Industrial Engineering or a related discipline is required. A Master’s degree is preferred.
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