Sr. Assembler

4 days ago

Fremont, California, United States Rani Therapeutics Full time


General Information
Position Title: Sr. Assembler
Department: Manufacturing
Reports to: Senior Production Supervisor
 
Position Overview
The Senior Manufacturing Assembler is responsible for performing advanced assembly operations for the manufacture of medical devices. This position requires fine hand dexterity, problem-solving skills, and the ability to work independently. The Senior Manufacturing Assembler plays a key role in ensuring product quality, training junior assemblers, and contributing to continuous improvement efforts within the production process.
Key Responsibilities
  • Perform assembly operations requiring fine hand dexterity with a high level of precision.
  • Proficiently assemble at least one assembly station or line with minimal supervision.
  • Ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in all tasks.
  • Comply with work schedules and accurately report hours worked.
  • Maintain legible and accurate records, including initialing, dating, and making clear notes.
  • Follow all written procedures and safety practices to ensure a safe working environment.
  • Read, comprehend, and follow written procedures and instructions in English.
  • Assist in writing and updating assembly procedures, protocols, and checklists.
  • Evaluate problems during assembly, make initial recommendations for corrective actions, and escalate issues as necessary.
  • Work with production management, Quality Assurance, and Manufacturing Engineers to improve assembly processes.
  • Provide continuous improvement suggestions to enhance production efficiency and quality.
  • Monitor and ensure the quality of work performed by less experienced assemblers.
  • Train and mentor junior-level assemblers, helping them to improve their skills and knowledge.
  • Ensure product and process quality by adhering to Quality System procedures.
  • Maintain compliance with government regulations to ensure product integrity and protect the company's reputation.
  • Identify potential issues on the assembly line and work proactively to resolve them.
  • Contribute to the team effort by accomplishing related results and supporting team goals.
  • Perform other duties as assigned.
Experience
  • 4-6 years of experience in a Medical Device or Pharmaceutical manufacturing environment.
  • Strong mechanical aptitude and ability to perform advanced assembly tasks.
  • Proven ability to work independently with minimal supervision.
  • Experience with training or mentoring junior team members is highly preferred.
  • Proficiency in basic arithmetic, measurements, and Microsoft Excel and Microsoft Word.
  • Ability to effectively collaborate with production management, engineers, and Quality Assurance to resolve issues and improve processes.
  • Medical device manufacturing experience is preferred.
  • Flexible and adaptable, with a comfortable demeanor when dealing with uncertainties.
Education
  • High School Diploma or equivalent.
  • Strong written and verbal communication skills in English.
  • Relevant certifications (e.g., Medical Device Manufacturing certification, GMP certification) are a plus.
Physical Demands
  • The employee is regularly required to stand, walk, and sit for extended periods during the performance of job duties.
  • Must be able to physically be present on-site to perform the required tasks.

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