Process Development Engineer II

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.