Sr. Process Engineer (Medical Device Transfer Specialist)
Spectraforce
Dublin, California
3 days ago
Job Description
Title: Sr. Process Engineer (Medical Device Transfer Specialist)
Duration: 12 Months
Location: Dublin, CA (94568)
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.
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $65.00/hr.
Duration: 12 Months
Location: Dublin, CA (94568)
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.
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $65.00/hr.