PDS&T Sr. Process Engineer (Medical Device Transfer Specialist)

Synectics Inc.; Dublin (CA); On-site; USD 110,000 - 165,000; Full time

Job summary

A leading company specializing in medical devices is seeking a skilled Process Engineer to oversee the transfer of manufacturing processes between facilities. This role requires an electrical or mechanical engineering background and a minimum of 8 years of experience in process engineering. The ideal candidate will have strong knowledge of regulatory standards and will collaborate with cross-functional teams to ensure compliance and operational efficiency during the transition.

Benefits

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Technical Certification Bonus

Qualifications

• 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.

Responsibilities

• Oversee the transfer of medical device manufacturing processes from one facility to another.
• Ensure all transferred processes comply with relevant industry standards and regulatory requirements.
• Develop and implement a comprehensive transfer plan, including timelines and risk assessments.

Skills

Project Management

Analytical Skills

Problem Solving

Cross-functional Collaboration

Education

Bachelor's degree in Electrical Engineering

Master's degree in Engineering or Related Field

Job description

PDS&T Sr. Process Engineer (Medical Device Transfer Specialist)

PDS&T Sr. Process Engineer (Medical Device Transfer Specialist)

5 days ago Be among the first 25 applicants

• Seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team and oversee 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.
• 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.
  
  

Job Summary

• Seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team and oversee 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.
• 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

• Bachelor's degree in electrical engineering, mechanical engineering, or a related field.
• Prefer a Master's degree in engineering or 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 skills.
• Prefer Experience with Lean, Six Sigma, or other process improvement methodologies.
• 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.
• Experience in automotive or aerospace is fine
  
  

California Fair Chance Act

Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Staffing and Recruiting

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