Process Development Engineer I

Cirtec - Brooklyn Park, MN

Full-time - Entry Level

Onsite - Brooklyn Park, MN

Publishing Industries

About the position

The Engineer I, Process Development at Cirtec Medical is primarily responsible for a functional project engineering group within the department, which consists of multiple engineering disciplines. This role involves the design, development, documentation, and validation of new customer products, as well as the modification of existing products. The engineer will define requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products. The Engineering team at Cirtec Medical is composed of professionals with diverse backgrounds and expertise, working closely with Operations, R&D, and Purchasing. The engineer will attend and arrange project meetings to discuss current and future design and development initiatives, track and communicate issues, and status on assigned action items that could affect timelines and budget. Responsibilities may include feasibility builds, equipment selection, process development, device verification samples and testing, operator training, and conducting Process Failure Mode Effects Analysis (PFMEA). Additionally, the engineer may be involved in product design and specification creation, materials sourcing, design verification and validation activities, and manufacturing transfer support for existing product lines. Compliance with company, quality, and safety standards, policies, and procedures is essential, along with the ability to perform other duties as assigned. This position is not remote, and reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Responsibilities

• Attend and arrange project meetings to discuss current and future design and development initiatives.
• Track and communicate issues and status on assigned action items that would affect timelines and budget.
• Manage project inputs including feasibility builds, documentation, and testing.
• Select equipment for projects as needed.
• Develop and document processes for product development.
• Conduct device verification samples and testing.
• Provide operator training for new processes and products.
• Perform Process Failure Mode Effects Analysis (PFMEA).
• Assist in clinical builds and process validation activities.
• Support product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
• Source materials and prototype devices as required.
• Conduct design verification and validation activities, including data for regulatory submission.
• Support manufacturing transfer and existing product lines as applicable.
• Comply with company, quality, and safety standards, policies, and procedures.

Requirements

• Bachelor's Degree required with 0 years of experience, or a combination of education and relevant work experience.
• Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
• Must maintain high ethical standards.
• Demonstrate good organizational skills.
• Fluent in reading, writing, and speaking English.
• Strong computer skills, including the MS Office suite and MS Project.
• Ability to interpret technical drawings, blueprints, specifications, and illustrations.
• Strong analytical skills to obtain, evaluate, and apply secondary research information.
• Ability to learn and apply new technology.
• Technical report preparation and good small group presentation skills.
• Willingness to travel, if required.

Benefits

• Fast-paced work environment.
• Ability to work on life-saving products.
• 401(k) retirement savings with a company match.
• Training and career development, with onboarding programs for new employees and tuition assistance.
• Financial security through competitive compensation, incentives, and retirement plans.
• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs.
• Paid time off.
• Clean, and well-lit production areas.