Director of Engineering

Summary:

This position provides leadership and guidance in the Engineering development and implementation of process improvements for optimal and efficient production operation. Directs the activities of the Process Engineering group in the management of process controls, documentation, data analyzation, new tooling and equipment requirements, new product launches and continuous improvement projects.

Key Duties and Responsibilities:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Develop and document manufacturing processes for medical devices (disposables) as inadhesive based wound care products, assembly, and packaging from concept throughmarket introduction.
• Drive process design and product design for manufacturability (DFM) to ensure robust andcapable manufacturing processes.
• Plan and execute assembly, documentation, qualification of manufacturing equipment.
• Plan and execute process characterization studies to determine optimal process windows.
• Plan and execute process validation including IQ, OQ and PQ activities.
• Design and procure process equipment, tooling, fixtures, and assembly aids.
• Implement process improvements and controls to ensure high product quality.
• Conduct process risk analysis (PFMEA) for products under development and implementprocess controls to drive risk mitigations.
• Prepare documentation release packages and obtain approvals.
• Ensure that all work satisfies the requirements of the company’s Quality Manual.
• Implement process and system automation systems.

Qualifications, Education and/or Experience Required:

• Position requires a minimum BS (or equivalent) in Chemical, Mechanical Engineering, ProcessEngineering or related field with proven achievements within field of technical expertise.
• Minimum 5 years’ experience working in a medical device manufacturing environment. Good computer literacy and a working knowledge of cGMP, ISO and FDA regulations preferred.
• Experience with Robotic technologies preferred.

Language Skills:

Reasonable accommodations can be made, up to and including translation services.

• English required, bilingual (Spanish) a plus.

Physical Demands:

• Position requires walking, standing for prolonged periods, occasionally required to sit, climb, or balance, stoop, kneel, crouch or crawl. May frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Other Duties:

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

AAP/EEO Statement:

• CHEMENCE® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
• This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.