Cirtec Medical · 1 day ago
Process Development Engineer II
Sturtevant, WI
Full-time
Onsite
Entry, Mid Level
2+ years expCirtec Medical is a leading outsourcing partner for complex medical devices, focusing on innovation and collaboration. The Process Development Engineer II will design, develop, and qualify manufacturing processes for medical devices, ensuring compliance with quality regulations and managing project timelines and deliverables.
ManufacturingMedical Device
Responsibilities
Attends and arranges project meetings to discuss current and future design and development initiatives
Serve as a primary contact with customers on programs of low to moderate complexity and serve as secondary contact with customers on programs of moderate to high complexity
Track and communicate the status of assigned action items that would affect timelines and budgets
Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner
Assist in the preparation and maintenance of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Provide input to program management for tracking and communicating project status, plans, issues, timelines, action items, and budgets
Responsible for the following project inputs: Feasibility builds, documentation, root cause analysis, and testing, Equipment selection and qualification, Process development and documentation, Device verification and samples testing, Operator training, Process failure mode effect analysis, Clinical builds, Process validation
Involvement in the full design, development, and validation requirements of programs, including: Product design and specification creation, including mechanical and electrical components, assemblies, and packaging, Materials sourcing and device prototyping, Design verification and validation activities, including data and regulatory submission, Manufacturing transfer and support of existing product lines as applicable
Reliable, consistent, and punctual attendance is an essential function of the job
Complies with company, quality and safety standards, policies, and procedures
Other duties as assigned
Qualification
Required
A Bachelor's degree in a STEM engineering discipline
2 years of experience; or a combination of education and relevant work experience in a STEM field
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
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
Stellar Technologies is manufacturer of precision components and assemblies.
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 StageTotal Funding
unknown2016-08-01Acquired
Leadership Team
Ed Philbin
Chief Financial Officer
Recent News
2025-10-02
2025-09-17
2025-08-29
Company data provided by crunchbase