Sr. Process Development Engineer

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:

As a Senior Process Development Engineer, you will play a key technical role in developing, optimizing, and validating manufacturing processes of medical devices in our active implantables group. You will lead cross-functional efforts from early feasibility through manufacturing transfer, ensuring robust, scalable, and compliant processes aligned with FDA and ISO 13485 requirements. You will also provide technical leadership, mentorship, and drive critical improvements across product development and manufacturing.

Key Responsibilities:

Process Development & Validation

- Develop, characterize, and optimize manufacturing processes, tools, fixtures, and equipment for medical device assemblies.

- Lead pFMEA creation, risk mitigation, root-cause investigations, and structured problem-solving activities (DOE, Six Sigma).

- Lead fixture design, prototyping, and evaluation.

- Plan and execute feasibility, DV, clinical, and validation builds with full traceability.

- Create and maintain high-quality process documentation including work instructions, travelers, BOMs, specifications, protocols, and technical reports.

- Assess and select new equipment, automation, and tooling solutions.

- Develop and execute IQ/OQ/PQ activities.

- Troubleshoot manufacturing processes and implement corrective actions.

Product & Manufacturing Integration

- Provide DFM input for materials, tolerances, and assembly processes.

- Support manufacturing transfers ensuring validated, documented, and scalable processes.

- Collaborate with Quality, Operations, and Program Management to ensure alignment from concept to launch.

Technical Leadership & Collaboration

- Mentor engineers, technicians, and cross-functional contributors.

- Serve as a technical interface on customer-facing programs.

- Support preparation of quotations, proposals, and technical justifications.

- Lead project activities including milestone planning, risk identification, and resource coordination.

- Support audits and FDA/ISO inspections.

- Drive continuous improvement initiatives.

Must Have:

- Bachelor’s degree in Engineering (STEM required).

- 5+ years of process development or manufacturing engineering experience (medical device preferred).

- Ability to interpret engineering drawings, tolerances, and specifications.

- Proficiency with Microsoft Office and Minitab.

- Experience developing or improving assembly processes.

- Knowledge of structured problem-solving, statistics, and engineering fundamentals.

- Experience with FDA QSR, ISO 13485, MDD, cGMP, GDP.

- Strong communication skills, written and verbal.

- High ethical standards.

- Fluent in English.

Good to have:

- Experience with active implantable devices or micro-assembly processes.

- Six Sigma training or certification.

- Root cause analysis expertise.

- Experience with automation, robotics, or advanced fixturing.

- Experience executing IQ/OQ/PQ in regulated environments.

- Willingness to travel, if needed.

Salary Range: Competitive salary range of $102,000-$132,000 based on skills and experience.

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.