IRRAS is globally selling IRRAflow® numerous supporting accessories and just launched its second product line, Hummingbird®. IRRAS is making decisive moves to internalize product research, design, development, manufacturing, and testing. IRRAS requires a Manufacturing Technical Lead to assist in the manufacture of its internalized products.
The Manufacturing Technician Lead is a key member of the Operations Team. Daily activities will range from hands on assembly of the IRRAS in house manufactured products to functional testing, packaging, material testing and receipt, troubleshooting device issues as well as interacting with the IRRAS ERP system, Jeeves. These activities demand a person who is organized, rational, and demonstrates strong associative thinking skills.
This person shall work with the Operations Team moving from task to task as determined by the commercial demands of the company. This individual shall have a quality oriented and self-driven nature. This role shall make a significant positive impact on product quality, cost of goods, and performance.
- System assembly and testing of the IRRAflow and Hummingbird products.
- Responsible for mechanical and electrical troubleshooting various IRRAS products.
- Implement improvements and innovate methods of resolving problems.
- Perform preventative maintenance and repair procedures on IRRAS manufacturing assets.
- Maintain manufacturing related procedures and records as per company standards.
- Test incoming materials for manufacturing process.
- Perform kitting and shipping activities as required
- Transact material movements in the IRRAS ERP system
- Execute material movement via forklift and pallet jack
- Train personal in procedures/policies regarding manufacturing process.
- Generate and update documentation for Operations.
- Work with Engineers, Operations/Manufacturing (internal customers) and vendors to run projects quickly, effectively and independently.
- Provide technical support for basic to complex projects.
- Continuously implement effective improvements to manufacturing process and procedures.
- Assist with product validations (IQ, OQ, PQ) including authoring and executing protocols.
- Demonstrates commitment to the development, implementation and effectiveness of the IRRAS Quality Management System per ISO 13485, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- May be required to work with biohazardous materials.
- May perform additional duties as assigned or directed by management from time to time
EDUCATION & EXPERIENCE:
- Minimum 3-5 years’ experience working with production equipment and assembling electromechanical products on a manufacturing line
- High school diploma or equivalent
- Experience in the manufacture of items of high safety risk
- Ability to synthesize complex issues, determine solutions, and implement difficult decisions
- Experience working in an expanding, high fast paced, and dynamic manufacturing environment
- Technical Degree or equivalent experience in related field
- Experience with hand and power tools and their associated safety procedures
- Experience working in GMP/ISO 13485 manufacturing environment
- Six Sigma Green or Black Belt is beneficial
- Demonstrates IRRAS core values as a foundation for building a culture of empathy, respect, team before self and sense of purpose.
- Impeccable attention to detail
- Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments.
- Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
- Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry.
- Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
- Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
- Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
- Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to walk, climb ladders, stoop, kneel, and crawl, for periods of up to 15 minutes
- Must be able to lift 50 lbs. from the ground to 4 feet on occasion
- Must have adequate vision correctable by regular corrective lenses for color coded electrical wiring
- Walking and conducting physical activities associated with completing equipment repair/replacement.
- Climbing ladders, crawling around and on top equipment, and above ceiling space.
- Moderate Lifting (up to 50 lbs.), pushing, pulling, moving, (furniture, equipment, machinery)
- Heavy lifting of equipment exceeding 50 lbs. with assistance from others and mechanical lifting equipment.
- Extreme physical activities as associated with large equipment/furniture relocation
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- General office and test lab environments
- Daily exposure to computers
- The noise level in the work environment is usually moderate
- Travel can be required
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
If you are interested in applying for employment with IRRAS please apply here.