Assembly II - 1st Shift

ASSEMBLY II- 1st Shift

Monday - Friday, 7:00 am - 3:30 pm, OT as required

Job Summary

The Assembly II is responsible for performing moderately complex assembly operations for medical device components, subassemblies, and finished products in accordance with approved Manufacturing Work Instructions (MWIs), drawings, specifications, and quality requirements. This position independently performs a variety of assembly processes, conducts in-process inspections, identifies and resolves routine production issues, and accurately completes required manufacturing and quality documentation. The Assembly II is expected to demonstrate proficiency in assigned processes, maintain high attention to detail, and consistently meet established quality and production standards while following applicable GMP, ISO, safety, and company procedures.

Essential Job Duties & Responsibilities

• Perform moderately complex assembly operations according to MWIs, drawings, specifications, and established procedures.
• Assemble medical device components, subassemblies, and finished products using hand tools, fixtures, gauges, and production equipment.
• Perform multiple assembly processes and demonstrate proficiency across assigned workstations.
• Read and accurately interpret Manufacturing Work Instructions (MWIs), drawings, specifications, and other controlled documents.
• Perform in-process inspections and visual examinations to verify product conformity.
• Identify defective components, materials, or assemblies and follow established procedures for handling nonconforming product.
• Make routine process adjustments within established procedures and escalate issues that require additional technical or supervisory support.
• Complete production records, inspection records, electronic transactions, and other required documentation accurately and in a timely manner.
• Maintain compliance with Good Manufacturing Practices (GMP) and applicable quality-system requirements.
• Follow established procedures for controlled environments and cleanroom operations, when applicable.
• Properly handle components and finished medical devices to prevent damage, contamination, or other quality issues.
• Meet established production, quality, efficiency, and workmanship standards.
• Maintain a clean, organized, and safe work area.
• Properly use and care for assigned tools, equipment, fixtures, and gauges.
• Assist with training and providing guidance to Assembly I employees, as requested.
• Communicate production, quality, material, equipment, or process concerns to the appropriate Lead, Supervisor, or other designated personnel.
• Participate in process improvement and problem-solving activities as assigned.
• Follow all company safety policies and procedures.
• Perform other duties as assigned.

Education & Experience Requirements

• Must be able to read, write, and communicate effectively in English to understand and accurately execute Manufacturing Work Instructions (MWIs), safety procedures, quality requirements, and other job-related documentation.
• High school diploma/GED or equivalent combination of education and experience.
• Minimum of 2 years of manufacturing or assembly experience or demonstrated proficiency equivalent to the requirements of an Assembly II.
• Demonstrated ability to independently perform assigned assembly processes.
• Ability to read, understand, and accurately execute Manufacturing Work Instructions (MWIs), drawings, specifications, and other job-related documentation.
• Strong attention to detail and ability to consistently produce quality work.
• Ability to use hand tools, fixtures, gauges, and other assembly equipment.
• Ability to accurately complete required production and quality documentation.
• Ability to recognize and communicate quality or process issues.
• Ability to work effectively both independently and as part of a team.

Preferred Skills & Abilities

• Previous medical-device, pharmaceutical, aerospace, or other regulated manufacturing experience.
• Experience working under GMP, ISO 13485, or similar quality-system requirements.
• Experience working in a cleanroom or controlled manufacturing environment.
• Experience assembling small or complex components.
• Experience using microscopes or magnification equipment.
• Experience training or mentoring less experienced employees.

Working Conditions

• Manufacturing/production environment.
• May work in a controlled environment or cleanroom, depending on the assigned production area.
• May be exposed to manufacturing equipment, noise, cleaning agents, and other typical production-area conditions.
• Required to follow applicable GMP, quality, safety, and cleanroom procedures.
• May require wearing appropriate personal protective equipment (PPE).
• Work may involve repetitive tasks and maintaining a consistent production pace.
• May be required to work overtime, weekends, or different shifts based on production needs

Physical Demands

This position requires frequent standing, sitting, reaching, handling, grasping, and repetitive hand and finger movements. The employee must be able to visually inspect components and perform precise assembly tasks. The position may occasionally require lifting and moving materials weighing up to 35 pounds.

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We offer a full complement of benefits including health, dental, vision, life insurance, LTD/STD, 401(k) and generous PTO. Come work for a growing company that offers a fun, collaborative environment with work-family balance.

Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

EOE/Disabled/Veteran

Pay: $20.00 - $23.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Vision insurance

Work Location: In person