Process Development Engineer II

Cirtec Medical; Lowell (MA); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Training and career development

Health care & wellness programs

Paid Time Off and 401(k)

Job summary

Cirtec Medical Corp. in Lowell, MA seeks an Engineer II – Process Development to design, develop, and qualify manufacturing processes for medical devices.

You will support product development, prototyping, process validation, and manufacturing transfer, working cross-functionally with engineering, quality, and operations. The role focuses on creating process specifications, PFMEA, risk controls, and documentation to meet regulatory standards.

Qualifications

• Bachelor’s degree in a STEM field.
• Minimum 2 years engineering experience.
• Experience with mechanical, tool design and manufacturing processes.
• Fluent English, able to read/write.
• Willingness to travel.
• Experience with Minitab and statistics.
• Ability to read technical drawings.
• Knowledge of documented change control processes.

Responsibilities

• Design, develop, and qualify manufacturing processes for medical-device products.
• Support product development activities including prototyping and process transfer.
• Serve as primary customer contact for low- to moderate-complexity programs.
• Coordinate meetings to review development activities and milestones.
• Develop work instructions, process specifications, and documentation.
• Perform PFMEA and implement risk controls.
• Provide technical training to production operators.
• Ensure compliance with quality systems and regulatory requirements.

Skills

B.S. in STEM

2+ years exp

Minitab stats

Technical drawings

English fluent

Process development

Education

Bachelor’s degree in STEM

Tools

PFMEA

Job description

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
• 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.

Benefits

• 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.