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:
- 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, Spanish a plus.
Physical Demands:
- Position requires sitting, walking, standing for prolonged periods, lifting.
Work Environment:
- Non-temperature-controlled warehouse, non-temperature-controlled production floor, temperature-controlled office.
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.
Life at Chemence
Chemence is a leading European manufacturer of high performance adhesives and sealants comprising instant adhesives (superglues), engineering anaerobics, threadlockers, retainers, gasket makers, gas pipe sealants, window and building plastics adhesives, non-staining activators and UV curing products. We supply globally to the retail, automotive, transportation, gas distribution, construction, medical and electronics. We also specialise in the production of flexographic plates, ink-jet film production systems. Chemence is the owner of several established brand names:- Mitre Mate: The original 2 part mitre bonding kit Kwik-Fix: A range of Value retail packaged adhesives designed for smaller retail outlets Setfast: A large and varied range of eye catching retail packaged consumer products Plastic Mate: high quality adhesives aimed at the professional user. The newest addition to our brands... Krylex: A range of high quality, high performance adhesives and sealants designed for industry Visit the dedicated website at http://www.krylex.com Industrial Adhesives & Sealants, Instant Adhesives (Cyanoacrylate/Superglue), Primers & Activators, UV Curing Resins, Anaerobic Gasket Makers & Pipe Sealants, Anaerobic Retainers & Threadlockers, Nail Glue & Resin, UV Soak-Off Nail Polish, UV Curing Nail Gel
Thrive Here & What We Value1. Provides equal employment opportunities to all employees and applicants for employment2. 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 laws3. Emphasis on maintaining a clean work environment4. Positive attitude towards work environment encouraged5. Reasonable accommodations made for individuals with disabilities6. Nontemperature-controlled warehouse and production floor environment7. Supports diversity and inclusion in the workplace
