Cirtec Medical · 6 hours ago
Sr. Process Development Engineer
Brooklyn Park, MN
Full-time
Onsite
Mid, Senior Level
$102K/yr - $132K/yr
5+ years expCirtec Medical is a leading outsourcing partner for complex medical devices, specializing in comprehensive solutions for Class II and III devices. The Senior Process Development Engineer will develop, optimize, and validate manufacturing processes for medical devices, ensuring compliance with FDA and ISO 13485 requirements while providing technical leadership and mentorship.
Medical Device
Responsibilities
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
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
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
Qualification
Required
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
Preferred
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
Benefits
Training and career development
Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid Time Off
401(k) retirement savings with a company match
Company
Cirtec Medical
Whether you’re a cutting-edge startup or a leading Class II or III medical device manufacturer, Cirtec is here to help bring life-enhancing therapies to market – quickly and cost-effectively.
1001-5000 employees
H1B Sponsorship
Cirtec Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (4)
2022 (2)
2021 (3)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Brian Highley
CEO
John Kraus
Chief Operations Officer
Recent News
2025-10-02
2025-09-17
2025-08-29
Company data provided by crunchbase