Medical Assembler

Company Overview. NuShores Biosciences LLC is a bone/tissue regeneration venture. We are currently designing and manufacturing the NuCress™ family of bone void filler scaffolds for orthopedic, dental, and spine bone implant indications to launch to market upon FDA clearance.

NuShores’ mission is to improve the quality of life for people globally while competing successfully by applying its licensed and internally developed advanced materials portfolio to the Biomaterials industry. NuShores has exclusive global license to patented bone and tissue regeneration technologies developed at University of Arkansas – Little Rock from over $15M in research.

Job Summary. We seek a Medical Assembler to join our production team. In this role, you will be working in a Clean Room Environment to set up production equipment, prepare raw materials for production, and verify that we have the correct ingredients to complete the production run successfully. As a Medical Assembler you will follow the appropriate SOPs, Work Instructions, drawings etc. that are part of the manufacturing process. As a Medical Assembler you will be operating manufacturing equipment used in the facilities; able to perform the entire manufacturing process and do quality checks, as well as packaging and labeling in coordination with other manufacturing personnel. You would keep accurate and timely records.

Come help us produce our NuCress™ scaffold product family, our award-winning bone void filler line of medical device products. If working with a smart and creative team that designs and builds products that improve quality of life interests you, then consider a career with us.

Medical Assembler Duties and Responsibilities. Our Medical Assembler will assist in the operations of our manufacturing facility and the products that we produce. Your duties could include organizing supplies and raw materials’ inventory and preparing equipment; and you could be involved in training others in preparation and production. You could also help to investigate the manufacturing process in order to fix any issues and ensure it meets strict regulations. In this position, you need troubleshooting skills and the ability to communicate with other manufacturing workers. You also need to be familiar with all of the relevant standards, regulations, and safety requirements that affect this job. You are responsible for following verbal and written procedures in operating production equipment and performing processing steps.
Under supervision, you would participate in technical procedures related to development and/or scale-up of production processes; and perform and/or support process development experiments according to protocols defined by research staff. You would ensure the highest possible product quality and adherence to quality; perform various operations on products in accordance with work orders. Work with Manufacturing Management and Quality to resolve manufacturing problems including drafting quality documentation (CAPA, deviation, change control). You would document material or process variance and communicate to the manufacturing supervisor or manager; and would interact with other support functions such as
Quality Assurance, Quality Control, Manufacturing Engineering, Validation. You would perform
Preventive Maintenance (PM) and CIP (Common Industrial Protocol) operations to prepare equipment for manufacturing operations, and visually inspect products to ensure conformity to specifications. You would help to maintain, calibrate, and trouble shoot critical process

equipment, and understand the product flow and processing systems and know the whereabouts of all storage areas. You would execute engineering and GMP production processes; strictly following cGMP, Quality, Safety and Work instruction requirements; and understand lean manufacturing and good manufacturing practices (GMP)/compliance. You would perform and/or support process development experiments according to protocols defined by research staff. You would help with plant cleaning (including floors, benches, equipment), waste disposal and monitor purification operations (including troubleshooting and diagnosis of instruments, equipment, process). Working with others, you would resolve problems with non-conforming products during the manufacturing process and communicate concerns to supervisor(s) and/or
Manufacturing Manager. You would accurately and timely record your completed work. You would help to perform packaging and material handling duties. You would assist with other tasks as needed.

Medical Assembler Requirements and Qualifications

• May be required to pass a pre-employment drug test.
• High school diploma or GED certificate; Associate degree (preferred).
• Previous Medical Assembly experience (preferred).
• Some laboratory (chemical, biological, materials, etc.) experience desired.
• Be flexible.
• Able to operate production equipment and facilities including start-up and shut down.
• Able to perform continuous quality monitoring.
• Be detailed oriented, quality conscious, and bring an aptitude for maintaining records.
• Being familiar with cGMP is a plus.
• Computer proficiency and the regular use of multiple software applications is ideal.
• Bring mechanical skills to handle a variety of manufacturing tools and equipment.
• Ability to work with products in a fume hood or laminar flow hood.
• Experience working with initiatives such as design for manufacturability (DFM), computer integrated manufacturing (CIM), flexible manufacturing and 3D technologies would be great but not required.
• Some knowledge in Lean transformation tools and techniques rooted in the Toyota

Production System, Kaizen methods, TPM, JIT, SMED would be great but not required.

• Language skills to communicate complex ideas effectively in English.
• Ability to move objects averaging 10 pounds, but up to 50 pounds daily.
• Ability to move easily and constantly during the day.
• Willing to work flexible schedules; nonstandard hours, evenings, or even night shift hours.
• WE LOVE OUR VETERANS; Applications from our veteran workforce are preferred.

Work Authorization. Proof of legal right to work in the US will be required of all candidates.

Job Type. Full-time employee.

Reporting. Chief Executive Officer (CEO), Chief Technical Officer (CTO) and/or Manufacturing
Manager.

Salary. National rates of pay / salary; competitive, with benefits.

Location. NuShores Biosciences is located in Little Rock,
Arkansas, a city of momentum and energy with strong institutions like Fortune 500 companies, urban universities and technical colleges, hospitals, arts, historic museums, and civil rights organizations. At the heart of the Natural State, Little Rock offers all the perks of an urban mid-size city with easy escapes to the bountiful surrounding nature (and its many biking and hiking trails, water sports, and outdoor adventures). Due to our solid economy, low cost of living and general quality of life, Little Rock is constantly featured in many quality-of-life lists from reputable magazines and blogs.

We love it here, and we know you will too. Find out more at littlerock.com.

To apply, please submit resume at www.nushores.com or email at info@nushores.com.

Job Type: Full-time

Pay: $15.49 - $22.00 per hour

Benefits:

• Flexible schedule
• Health insurance
• Paid time off
• Professional development assistance
• Tuition reimbursement

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Little Rock, AR 72211: Reliably commute or planning to relocate before starting work (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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