Process Manufacturing Engineer Job at Wall Street Consulting Services LLC, California

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  • Wall Street Consulting Services LLC
  • California

Job Description

Job Title: Process Manufacturing Engineer

Location: Dublin, CA 94568

Duration: 12 Months, extension possible based on needs and performance Months

Job Description:

100% Onsite

Day shift M-F 8-5 some flexibility, possible some weekends occasionally

Position Title: PDS&T Sr. Process Engineer (Medical Device Transfer Specialist)/Engineer III

Transfer and process validation from one facility to another facility

will need to travel internationally to costa Rica once in a couple of months (2 -3 weeks' notice will be given before travel)

Spanish is a plus but not a must have

  • Get product in to production line and then move it to costa rica
  • Will be on production lines seeing equipment is according to specifications.
  • Engineering Electrical or Mechanical
  • Medical Device experience in manufacturing: preferably electrical mechanical devices.
  • Will generate a lot of reports and protocols
  • Will work on production issues to get product moved
  • Experience with Lean, Six Sigma, or other process improvement methodologies. (Nice to have and not needed)

Top skills

  • Exp in transfer of product from one facility to another (Transfer of products it could be experience of product transfer from R&D to manufacturing or product transfer from site to site.)
  • Electrical or mechanical engineering background

Job Summary:

  • We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team.
  • The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules.

Key Responsibilities:

  • Design History File: Ensure that the transferred process is adhering to the Device Master Record.
  • Process Analysis and Documentation: Analyze current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities.
  • Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure smooth transition between facilities.
  • Cross-functional Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Supply Chain, to align objectives and address any challenges during the transfer process.
  • Regulatory Compliance: Ensure all transferred processes comply with relevant industry standards, regulatory requirements, and quality assurance protocols.
  • Equipment and Technology Alignment: Evaluate existing equipment and technologies to determine compatibility at the receiving facility; recommend upgrades or changes if necessary.
  • Process validation: Ensure that equipment qualification is in compliance with the product requirements.
  • Training and Support: Provide training and support to facility teams to ensure they are equipped to manage new processes effectively.
  • Continuous Improvement: Identify opportunities for process optimization and efficiency improvements before and after the transfer.
  • Reporting and Documentation: Maintain detailed records of transfer activities and provide regular reports to management on progress, risks, and outcomes.

Qualifications :

  • A bachelor's degree in electrical engineering, mechanical engineering, or a related field.
  • Minimum of 8 years of experience in process engineering, preferably within the medical device industry.
  • Proven experience in transferring manufacturing processes between facilities.
  • Strong knowledge of regulatory requirements and quality standards for medical device manufacturing.
  • Excellent project management and organizational skills.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.

Preferred Qualifications:

  • Master's degree in engineering or related field.
  • Experience with Lean, Six Sigma, or other process improvement methodologies.

Remote, 100% Onsite, or Hybrid Onsite Schedule: 100% Onsite: Schedule is Monday to Friday from 8am to 5pm

What are the top 3-5 skills, experience or education required for this position:

  • Engineering Electrical or Mechanical preferable.
  • Medical Device experience in manufacturing: preferably electrical mechanical devices.
  • Transfer of products it could be experience of product transfer from R&D to manufacturing or product transfer from site to site.

Good interpersonal skills writing and speaking.

Job Tags

Remote job, Weekend work, Day shift, Monday to Friday,

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