Experience in mechanical, tool design, and manufacturing processes (medical device preferred)
Strong computer skills, including MS Office and Minitab
Ability to interpret technical drawings and specifications
Strong analytical skills with a focus on secondary research
Technical report preparation and presentation skills
Responsibilities
Design, develop, document, and qualify manufacturing processes for medical devices
Support product development activities including feasibility studies and prototyping
Serve as primary customer contact for low- to moderate-complexity programs
Coordinate project meetings to review development activities and milestones
Collaborate with Program Management to track project plans and budgets
Lead feasibility builds and engineering testing
Perform process risk assessments and implement controls
Benefits
Collaborative cross-functional work environment
Opportunities for professional development and training
Exposure to cutting-edge medical device technologies
Engagement in meaningful projects that impact patient care
Potential for travel to support project needs
Full Job Description
Description
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.
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
About Cirtec Medical
Cirtec Medical is a medical device company that designs, develops, and manufactures implantable medical devices and components. The company's products are used in a variety of medical applications, including cardiovascular, orthopedic, and neurological procedures. Cirtec Medical was founded in 2014 and is headquartered in Irvine, California.
