Process Engineer in Dublin, CA

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

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.

, 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.

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