Staff Chemical Process Engineer

Stryker•Arlington, TN

20h•Onsite

About The Position

Stryker is hiring a Staff Chemical Process Engineer. In this role, you will develop and modify chemical process formulations, methods, and controls to meet quality standards, while recommending and implementing improvements to documentation. They will also review product development requirements to ensure compatibility with processing methods and integrate equipment and material capabilities to meet target specifications, costs, and schedules. This is an onsite role in Arlington, TN. What you will do: Provide engineering support and leadership for product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker product procedures Ensure quality of process and product as defined in the appropriate operation and material specifications Lead the specification, development and implementation of manufacturing equipment based on analysis of specifications, reliability and regulatory requirements Analyze equipment and processes to establish operating data and conduct experimental test and result analysis Lead and participate in process review meetings Evaluate process layouts in terms of supporting new process integration while ensuring best utilization of floor space ensuring optimum process flow Lead and participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches Conduct process validations and measurement systems analysis (MSA) studies for new products and new processes Review and approve validation documentation Drive and execute effective communication with all stakeholders to enable project success Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations Lead creation and refinement of engineering documentation Provide training for manufacturing team members Ensure adherence to good manufacturing practices (GMP) and safety procedures

Requirements

B.S. in Chemical, Mechanical, Manufacturing Engineering or related technical discipline
4+ years of manufacturing engineering or automation experience

Nice To Haves

M.S. in Chemical Engineering
FDA-regulated manufacturing/industry environment experience
Knowledge of chemical processes for surface treatment
Demonstrated experience in the field of formulations mixing (industrial process engineering)
Custom automation experience
Demonstrated experience writing and executing validations (IQ, OQ, PV, etc.)
Demonstrated experience owning and resolving quality non-conformances and CAPAs

Responsibilities

Provide engineering support and leadership for product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker product procedures
Ensure quality of process and product as defined in the appropriate operation and material specifications
Lead the specification, development and implementation of manufacturing equipment based on analysis of specifications, reliability and regulatory requirements
Analyze equipment and processes to establish operating data and conduct experimental test and result analysis
Lead and participate in process review meetings
Evaluate process layouts in terms of supporting new process integration while ensuring best utilization of floor space ensuring optimum process flow
Lead and participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches
Conduct process validations and measurement systems analysis (MSA) studies for new products and new processes
Review and approve validation documentation
Drive and execute effective communication with all stakeholders to enable project success
Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations
Lead creation and refinement of engineering documentation
Provide training for manufacturing team members
Ensure adherence to good manufacturing practices (GMP) and safety procedures