Process Development Engineer II — MedTech Impact

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

Job summary

Cirtec Medical, a leading medical device outsourcing partner, is seeking an Engineer II - Process Development in Lowell, MA. You will design, develop, and qualify manufacturing processes for Class II/III devices, supporting prototyping, design verification, process validation, and production transfers.

You will collaborate with Engineering, Quality, Operations, and customers, prepare technical documentation, and guide manufacturing teams to meet timelines, quality standards, and regulatory

Qualifications

• Bachelor's degree in a STEM related field is 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.

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 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.

Skills

Analytical skills

Cross-functional teamwork

Blueprint reading

Statistical analysis

Technical drawing interpretation

Willingness to travel

Education

Bachelor's degree in a STEM related field

Tools

Minitab

MS Office

Job description

Cirtec Medical, a leading medical device outsourcing partner, is seeking an Engineer II - Process Development in Lowell, MA. You will design, develop, and qualify manufacturing processes for Class II/III devices, supporting prototyping, design verification, process validation, and production transfers.

You will collaborate with Engineering, Quality, Operations, and customers, prepare technical documentation, and guide manufacturing teams to meet timelines, quality standards, and regulatory