Process Development Engineer Jobs in USA with Visa Sponsorship
Process Development Engineer jobs attract strong visa sponsorship from manufacturers, biopharma companies, and semiconductor firms that rely on specialized technical talent. H-1B visa is the most common path, with employers filing an LCA before petitioning USCIS. TN visa and E-3 visa are faster options for Canadian, Mexican, and Australian engineers in qualifying roles. For detailed occupation requirements, see the O*NET profile.
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About us:
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!
Position Summary:
The Engineer II - Process Development is responsible for designing, developing, and qualifying manufacturing processes for medical devices. This role supports new product development and modifications to existing products, including prototyping, process development, design verification, clinical builds, process validation, and manufacturing transfer. The position works cross-functionally with Engineering, Quality, Operations, Program Management, and customers to ensure manufacturing processes meet technical requirements, project timelines, quality standards, and regulatory expectations.
Key Responsibilities:
- Design, develop, document, and qualify manufacturing processes for new and existing medical-device products.
- Support product development activities, including feasibility studies, prototyping, process optimization, design verification, clinical builds, and manufacturing transfer.
- Serve as the primary customer contact for low- to moderate-complexity programs and provide support on more complex projects.
- Participate in and coordinate project meetings to review development activities, technical challenges, project milestones, and deliverables.
- Collaborate with Program Management to develop and maintain project plans, track action items, monitor budgets, and ensure project timelines are met.
- Assist in preparing customer proposals, quotations, and technical documentation while addressing customer inquiries and project requirements.
- Lead or support feasibility builds, engineering testing, root cause investigations, and technical documentation.
- Support equipment selection, qualification, and implementation to ensure manufacturing processes meet performance and quality requirements.
- Develop manufacturing processes, work instructions, process specifications, and supporting documentation.
- Perform process risk assessments, including Process Failure Mode and Effects Analysis (PFMEA), to identify potential risks and implement appropriate controls.
- Support product design activities, including mechanical and electrical components, assemblies, packaging, material selection, and prototype development.
- Coordinate design verification and validation activities, including sample preparation, testing, data analysis, and documentation supporting regulatory submissions.
- Support process validation activities and ensure manufacturing processes are prepared for successful production transfer.
- Provide technical training and guidance to production operators to ensure proper implementation of manufacturing processes.
- Collaborate with cross-functional teams to resolve technical issues, improve manufacturing processes, and support existing product lines.
- Prepare technical reports, engineering documentation, and presentations to communicate project results and recommendations.
- Ensure compliance with company quality systems, safety policies, regulatory requirements, and standard operating procedures.
Must Have:
- Bachelor's degree in a STEM related field, required
- Minimum of 2 years' engineering related experience
- Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
- Willingness to travel, if required
- Must maintain high ethical standards
- Must demonstrate good organizational skills
- Must be able to read, write and speak fluent English
- Strong computer skills, including MS Office
- Experience with Minitab and statistical analysis
- Experience with documented change control processes.
- Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
- Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
- Ability to learn and apply new technology
- Technical report preparation and formal presentation skills
Good to Have:
- Experience in medical-device manufacturing or another highly regulated industry.
- Familiarity with medical-device design controls, process validation, and manufacturing transfer activities.
- Experience supporting new-product introductions, feasibility builds, clinical builds, and prototype development.
- Knowledge of equipment selection, qualification, and manufacturing process optimization.
- Familiarity with Process Failure Mode and Effects Analysis (PFMEA) and risk-based engineering methodologies.
- Experience supporting design verification and validation testing, including documentation for regulatory submissions.
- Experience with customer-facing engineering projects, technical proposals, and project coordination.
- Familiarity with root cause analysis, continuous-improvement methodologies, and structured problem-solving techniques.
Salary Range: $80,000 - $90,000
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Description
About us:
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!
Position Summary:
The Engineer II - Process Development is responsible for designing, developing, and qualifying manufacturing processes for medical devices. This role supports new product development and modifications to existing products, including prototyping, process development, design verification, clinical builds, process validation, and manufacturing transfer. The position works cross-functionally with Engineering, Quality, Operations, Program Management, and customers to ensure manufacturing processes meet technical requirements, project timelines, quality standards, and regulatory expectations.
Key Responsibilities:
- Design, develop, document, and qualify manufacturing processes for new and existing medical-device products.
- Support product development activities, including feasibility studies, prototyping, process optimization, design verification, clinical builds, and manufacturing transfer.
- Serve as the primary customer contact for low- to moderate-complexity programs and provide support on more complex projects.
- Participate in and coordinate project meetings to review development activities, technical challenges, project milestones, and deliverables.
- Collaborate with Program Management to develop and maintain project plans, track action items, monitor budgets, and ensure project timelines are met.
- Assist in preparing customer proposals, quotations, and technical documentation while addressing customer inquiries and project requirements.
- Lead or support feasibility builds, engineering testing, root cause investigations, and technical documentation.
- Support equipment selection, qualification, and implementation to ensure manufacturing processes meet performance and quality requirements.
- Develop manufacturing processes, work instructions, process specifications, and supporting documentation.
- Perform process risk assessments, including Process Failure Mode and Effects Analysis (PFMEA), to identify potential risks and implement appropriate controls.
- Support product design activities, including mechanical and electrical components, assemblies, packaging, material selection, and prototype development.
- Coordinate design verification and validation activities, including sample preparation, testing, data analysis, and documentation supporting regulatory submissions.
- Support process validation activities and ensure manufacturing processes are prepared for successful production transfer.
- Provide technical training and guidance to production operators to ensure proper implementation of manufacturing processes.
- Collaborate with cross-functional teams to resolve technical issues, improve manufacturing processes, and support existing product lines.
- Prepare technical reports, engineering documentation, and presentations to communicate project results and recommendations.
- Ensure compliance with company quality systems, safety policies, regulatory requirements, and standard operating procedures.
Must Have:
- Bachelor's degree in a STEM related field, required
- Minimum of 2 years' engineering related experience
- Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
- Willingness to travel, if required
- Must maintain high ethical standards
- Must demonstrate good organizational skills
- Must be able to read, write and speak fluent English
- Strong computer skills, including MS Office
- Experience with Minitab and statistical analysis
- Experience with documented change control processes.
- Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
- Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
- Ability to learn and apply new technology
- Technical report preparation and formal presentation skills
Good to Have:
- Experience in medical-device manufacturing or another highly regulated industry.
- Familiarity with medical-device design controls, process validation, and manufacturing transfer activities.
- Experience supporting new-product introductions, feasibility builds, clinical builds, and prototype development.
- Knowledge of equipment selection, qualification, and manufacturing process optimization.
- Familiarity with Process Failure Mode and Effects Analysis (PFMEA) and risk-based engineering methodologies.
- Experience supporting design verification and validation testing, including documentation for regulatory submissions.
- Experience with customer-facing engineering projects, technical proposals, and project coordination.
- Familiarity with root cause analysis, continuous-improvement methodologies, and structured problem-solving techniques.
Salary Range: $80,000 - $90,000
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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Get Access To All JobsTips for Finding Visa Sponsorship as a Process Development Engineer
Map your degree to the role
Process development engineering typically requires a bachelor's in chemical engineering, materials science, or a closely related field. Document how your coursework directly maps to process optimization, scale-up, or unit operations, a vague degree-to-role connection is a common H-1B RFE trigger.
Target industries with active LCA filings
Biopharma, semiconductor fabrication, and specialty chemicals file LCAs for process engineers far more consistently than general manufacturers. Search OFLC public disclosure data to identify which employers certified positions matching your process area, whether that's upstream biologics, CVD deposition, or polymer extrusion.
Verify prevailing wage before negotiating
Your employer's LCA must certify a wage at or above the DOL prevailing wage for your location and role level. Use the OFLC Wage Search to confirm the Level I through Level IV thresholds for your metro area before you enter salary discussions, so you're not blindsided post-offer.
Use Migrate Mate to find verified sponsors
Many process engineering roles never list visa sponsorship explicitly in job postings. Migrate Mate surfaces employers with verified LCA filing history for engineering roles, so you can focus your applications on companies that have actually sponsored before rather than guessing from job descriptions.
Ask about PERM timing if you want permanence
Some employers start PERM labor certification within the first H-1B period for hard-to-fill process roles. Ask during the offer stage whether the company has a policy on sponsoring green cards for engineers, since PERM timelines can run two or more years before you file the I-140.
Clarify visa type eligibility before accepting
If you're a Canadian or Mexican national, TN status covers engineers under USMCA and can be obtained at a port of entry without a petition, making it faster than H-1B. Confirm with the employer that they're open to TN before the offer is finalized, since not all HR teams know the process.
Frequently Asked Questions
Does a process development engineer role qualify as a specialty occupation for H-1B?
Yes, in most cases. USCIS looks for roles that require at least a bachelor's degree in a directly related field like chemical engineering, materials science, or bioengineering. Where applications get challenged is when job descriptions include language like 'bachelor's preferred' or accept unrelated degrees, employers should tighten job requirements before filing the LCA to reduce RFE risk.
Which visa types are available to process development engineers seeking U.S. sponsorship?
H-1B is the most common path and requires employer sponsorship plus an annual cap and selection process. Canadian and Mexican nationals can pursue TN status under USMCA, which covers engineers and has no numerical cap. Australian nationals can apply for the E-3 visa, which also has no lottery and allows renewable two-year status. Each path requires a confirmed job offer before the employer can file.
How do I find employers who have actually sponsored process engineers before?
Migrate Mate lists employers with verified LCA filing history for engineering roles, so you can browse companies that have sponsored process development positions rather than applying speculatively. This is especially useful in biopharma and semiconductor sectors, where sponsorship practices vary widely between sites even within the same company.
What degree fields support a process development engineer H-1B application?
Chemical engineering is the most defensible degree for process development roles, followed by materials science, biochemical engineering, and mechanical engineering when the work involves fluid systems or thermal processing. Degrees in chemistry or biology can support H-1B petitions in biopharma process roles, but the employer needs to show a direct connection between the degree field and the specific job duties.
Can a process development engineer on OPT transition to H-1B with the same employer?
Yes. If you're working in a qualifying process engineering role on OPT, your employer can file an H-1B petition on your behalf subject to the annual cap and selection process. STEM OPT extends F-1 work authorization by 24 months for degrees in qualifying engineering fields, which gives you additional time if you aren't selected in an earlier registration cycle. Your employer must be enrolled in E-Verify to sponsor STEM OPT.
What is the prevailing wage requirement for sponsored Process Development Engineer jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.