Manufacturing Engineer II
Job Description
Overview
CORTLAND BIOMEDICAL – Who we are?
Cortland Biomedical custom builds high-performance biomedical textile structures
The company applies over 40 years of experience in textile engineering and advanced fabric design methods to braid, knit and woven products that meet the demands of a diverse set of customers in the biomedical product space
The company also offers a full range of design, development and manufacturing services as well as a wide variety of biomedical materials
Never comfortable with the status quo, complex biomedical textile challenges are tackled with agility, credibility and curiosity.
Cortland Biomedical is wholly owned by Enerpac Tool Group
Enerpac Tool Group is a premier industrial tools and services company serving a broad and diverse set of customers in more than 25 countries
The Company’s businesses are global leaders in high pressure hydraulic tools, controlled force products and solutions for precise positioning of heavy loads that help customers safely and reliably tackle some of the most challenging jobs around the world
The Company was founded in 1910 and is headquartered in Menomonee Falls, Wisconsin
Enerpac Tool Group trades on the NYSE under the symbol “EPAC”.
For further information on Cortland Biomedical, visit the Company's website at https://www.cortlandbiomedical.com/
For further information on Enerpac Tool Group and its businesses, visit the Company's website at https://www.enerpactoolgroup.com/.
Summary – basic function of the role
Oversees the implementation of world class manufacturing processes and equipment using diversified knowledge and engineering principles that deliver product safety, quality as well as cost efficiency for the business’ biomedical textile products. Maintains processes, manufacturing methods, techniques, practices, and procedures in support of ISO13485:2016 International Standard for Medical Devices and Good Manufacturing Practices
Lead and participate in continuous improvement activity to ensure Cortland Biomedical meets/exceeds management and customer expectations
Creates and maintains professional development and strategic plans for a technical team of engineers, technicians and maintenance professionals
Promotes strong team collaboration between functional areas including operations, quality, new product development, and sales.
Work Schedule: Monday – Friday; evenings and weekends may be required
Location: In-office Monday – Friday
850 Lime Hollow Rd.
Cortland, NY13045
Salary Range: $86,330 - $129,500
This role is not eligible for sponsorship.
Job Duties and Responsibilities
- Develop a high-performance manufacturing team by hiring, training, coaching, developing, and establishing performance and development objectives.
- Support Director of Operations and overall leadership team in setting operational strategy of the business.
- Establish, implement, and maintain safety policy and procedure in accordance with site requirements and at the direction from corporate health and safety.
- Ensure cross functional safety reviews for manufacturing equipment and processes.
- Lead establishment, implementation and maintenance of PFMEAs, Quality Plans, Procedures, Work Instructions, Forms and other QMS documentation once design is transferred to commercial production from new product development.
- Lead and mentor effective problem-solving activities including Corrective Action and Preventative Action (CAPA) assignments.
- Lead and facilitate engineering change including master list, timelines, job assignments, and customer communication when applicable.
- Support the creation and management of product BOMS and routers within the company’s ERP system and ensuring appropriate financial, engineering and Quality Management system (QMS) standards.
- Lead the budget, identification, tracking, logistics and installation of new capital equipment including potential travel to suppliers for site acceptance testing.
- Support execution of equipment installation and operational qualifications, process characterizations, performance qualifications and other scientific protocols to support the creation of statistically based product specifications.
- Lead creation, implementation and maintenance of Continuous Improvement methodologies including, but not limited to: 5S, Standardized Work, TPM, Pull Systems, etc. leveraging the corporate LEAD model.
- Manage key operational cost reduction initiatives for the site.
- Develop new technological solutions to manufacturing challenges including the use of digital tools for product documentation and traceability.
- Expand Cortland Biomedical’s expertise in state-of-the-art engineering, manufacturing methods and materials utilization through technical journals, seminars, advance degree programs, etc.
- Drive improvements to material requirements planning and controls.
- <10% domestic and international travel in support of customers, engineering projects, site acceptance tests and training.
Skills and Competencies
- 3-5 years experience working within a ISO13485 or ISO9001 manufacturing environment (or similarly regulated).
- Effective verbal and written communication skills and comfortable interacting with team members and customers at all levels.
- Must have demonstrated creative problem solving and effective engineering decision making skills.
- Ability to make autonomous decisions based on thorough understanding of business objectives.
- Ability to work collaboratively with other functions.
- Proven ability to manage multiple priorities under tight timelines.
- Capable of generating and delivering presentations to management, peers and labor force.
- Familiar with the physical and mechanical characteristics of polymers, fibers, yarns and fabrics a plus.
- Knowledge of textile processing and equipment for braiding, knitting and/or weaving a plus.
- Experience with Enterprise Resource Platforms (ERP) / Material Requirments Planning (MRP) preferred.
HSQE customer and company requirements:
- To be a leader of safety and quality best practices including support of new process and procedure development.
- To always ensure that their acts or omissions do not present a danger to themselves, anyone else, the environment or the safe operation of any plant or equipment.
- To intervene and report any defect in equipment or practice or any dangerous circumstance or event which could affect HSQE performance.
- To comply with all HSQE customer and company requirements.
Leadership Expectations: