Process Engineer - Actalent
Irvine, CA
About the Job
Job Title: Process Development Engineer
For immediate consideration, please apply directly to this job posting AND email habels @actalentservices.com with the following:
1) Word copy of resume
2) 2-3 professional references
3) 4-5 brief bullet points highlighting technical qualifications
Job Description
We are seeking a Process Development Engineer to join our team. You will work closely with Design Engineering, purchasing, and production teams to develop and validate manufacturing processes for Class II medical devices. This role involves hands-on development of manufacturing processes, equipment qualification, and continuous improvement initiatives.
Responsibilities
+ Collaborate with Design Engineering to identify Design for Manufacturability and Assembly targets.
+ Partner with purchasing to ensure all needed materials are procured per process development/validation/training needs and the first year forecast.
+ Plan and coordinate the execution of process characterization and validation.
+ Complete all Process Development Engineering elements of the PDP by milestone dates.
+ Work with production to ensure all LMR builds and the first 3 months of commercial builds are completed on time.
+ Create all required documents, including manufacturing processes, protocols, and reports.
+ Ensure process capability and yield targets are met.
+ Provide mentoring and direction to junior technical staff.
+ Develop manufacturing processes hands-on.
+ Design, develop, and qualify tooling/equipment (IQ).
+ Develop and qualify in-process test methods (TMV, test method validation).
+ Present status of plans and projects to the larger team.
+ Develop requirements and procure equipment for manufacturing processes.
+ Lead small teams for process development or problem solving.
Essential Skills
+ Experience in lean manufacturing.
+ Familiarity with Class II medical devices.
+ Expertise in process development.
+ Knowledge of catheter manufacturing.
+ Continuous improvement skills.
+ Proficiency in Six Sigma.
+ Experience in protocol writing and PFMECAS.
Additional Skills & Qualifications
+ Bachelor's degree in an engineering/technical discipline.
+ Minimum of 2 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience.
Work Environment
For 40 years, our client has been a global leader in the innovation of novel products for the interventional access and treatment of neurovascular diseases. You will work in a fast-paced environment with cutting-edge technology, and collaborate on cross-functional teams. The role offers the possibility for duration to be extended an additional 3-5 months or to become permanent.
Pay and Benefits
The pay range for this position is $45.00 - $60.00
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Irvine,CA.
Application Deadline
This position will be accepting applications until Feb 7, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
For immediate consideration, please apply directly to this job posting AND email habels @actalentservices.com with the following:
1) Word copy of resume
2) 2-3 professional references
3) 4-5 brief bullet points highlighting technical qualifications
Job Description
We are seeking a Process Development Engineer to join our team. You will work closely with Design Engineering, purchasing, and production teams to develop and validate manufacturing processes for Class II medical devices. This role involves hands-on development of manufacturing processes, equipment qualification, and continuous improvement initiatives.
Responsibilities
+ Collaborate with Design Engineering to identify Design for Manufacturability and Assembly targets.
+ Partner with purchasing to ensure all needed materials are procured per process development/validation/training needs and the first year forecast.
+ Plan and coordinate the execution of process characterization and validation.
+ Complete all Process Development Engineering elements of the PDP by milestone dates.
+ Work with production to ensure all LMR builds and the first 3 months of commercial builds are completed on time.
+ Create all required documents, including manufacturing processes, protocols, and reports.
+ Ensure process capability and yield targets are met.
+ Provide mentoring and direction to junior technical staff.
+ Develop manufacturing processes hands-on.
+ Design, develop, and qualify tooling/equipment (IQ).
+ Develop and qualify in-process test methods (TMV, test method validation).
+ Present status of plans and projects to the larger team.
+ Develop requirements and procure equipment for manufacturing processes.
+ Lead small teams for process development or problem solving.
Essential Skills
+ Experience in lean manufacturing.
+ Familiarity with Class II medical devices.
+ Expertise in process development.
+ Knowledge of catheter manufacturing.
+ Continuous improvement skills.
+ Proficiency in Six Sigma.
+ Experience in protocol writing and PFMECAS.
Additional Skills & Qualifications
+ Bachelor's degree in an engineering/technical discipline.
+ Minimum of 2 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience.
Work Environment
For 40 years, our client has been a global leader in the innovation of novel products for the interventional access and treatment of neurovascular diseases. You will work in a fast-paced environment with cutting-edge technology, and collaborate on cross-functional teams. The role offers the possibility for duration to be extended an additional 3-5 months or to become permanent.
Pay and Benefits
The pay range for this position is $45.00 - $60.00
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Irvine,CA.
Application Deadline
This position will be accepting applications until Feb 7, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Source : Actalent