Job Description

SUMMARY:

The Staff Manufacturing Engineer role is part of the Advanced Engineering (AE); Transformative Technology team within the Life Sciences and Lab Products Group (LSLPG).

The person will be responsible for primary technical support to projects that require engineering and technology improvements across LSLPG and secondary support to other groups/divisions/sites as required.

The person will apply technical or scientific knowledge to drive engineering controls, operational improvements, technology advancement, reduced Quality risks and improved sustainability for increased capacity and profitability within industrial, electronics, mechanical, or chemical processes

Job Duties and General Responsibilities:

* Lead or be the Subject Matter Expert (SME) for advanced engineering and technology initiatives on technical projects, including equipment/ systems/ processes.
* Develop or optimize design controls, including requirements, specifications, and risk management
* Develop or optimize automated equipment/ systems/ processes for future state manufacturing
* Develop or optimize engineering controls to support commissioning and validation activities
* Develop or optimize procedures, drawings, solid-models, etc. for improved efficiencies
* Participates in PPI initiatives such as LEAN, continuous improvements, increased capacity, etc.
* Create or support Quality controls for processes, equipment, or systems.
* Write &/or execute validation protocols and reports for equipment/ systems/ or processes
* Lead independent or teams to research, prepare, and present technical reports to departments, committees, commissions, propose ordinance and policy revisions.

Additional responsibilities:

* Maintains standard operating procedures (SOP) and Change Orders (CO) for the engineering function
* Liaison to cross-functional groups/ divisions/ departments regarding engineering projects.
* Comply with GMP standards and regulations (ie ISO 90001, ISO 13485, 21 CFRs, etc)
* Support the application of engineering principles and practices for an assigned area of responsibility.
* Can provide training to Engineers, indirect support staff, and interns.

Minimum Requirements:

Education:

* Bachelor's degree in Engineering (manufacturing, mechanical, industrial, electromechanical or equivalent)
* Higher education preferred (ie Master2019s degree, Certifications, etc.)

Experience:

* Five [5] or more years as an Engineering lead or SME for the design or manufacture of medical devices, diagnostics, equipment, systems, processes, assemblies, new product introduction (NPI), continuous improvements, etc.

Language(s):

* Primary - English

Specialized Skills:

* Proficient in Design Controls and Risk Management
* - Proficient in manufacturing processes (ie. Medical Device, Diagnostics, Bio, Pharma)
* - Proficient with GMPs and regulations (21CFR, ISO 90001, ISO 13485)
* - Intermediate in Computer Aided Design (ACAD, Solidworks, etc.)
* - Knowledge of Lean Manufacturing, certification preferred
* - Preferred certification in Six Sigma
* - Preferred knowledge or experiences with Future-Factory or Industry/ MFG 4.0